Kidney exchange in the U.S. from 2006-2021

 Here's an interesting look at the (ongoing) development of kidney exchange in the U.S

Temporal trends in kidney paired donation in the United States: 2006-2021 UNOS/OPTN database analysis, by Neetika Garg, Carrie Thiessen, Peter P. Reese, Matthew Cooper, Ruthanne Leishman, John Friedewald, Asif A. Sharfuddin, Angie G. Nishio Lucar, Darshana M. Dadhania, Vineeta Kumar, Amy D. Waterman, and Didier A. Mandelbrot, American Journal of Transplantation,  24, 1, P46-56, JANUARY 2024.

Abstract: Kidney paired donation (KPD) is a major innovation that is changing the landscape of kidney transplantation in the United States. We used the 2006-2021 United Network for Organ Sharing data to examine trends over time. KPD is increasing, with 1 in 5 living donor kidney transplants (LDKTs) in 2021 facilitated by KPD. The proportion of LDKT performed via KPD was comparable for non-Whites and Whites. An increasing proportion of KPD transplants are going to non-Whites. End-chain recipients are not identified in the database. To what extent these trends reflect how end-chain kidneys are allocated, as opposed to increase in living donation among minorities, remains unclear. Half the LDKT in 2021 in sensitized (panel reactive antibody ≥ 80%) and highly sensitized (panel reactive antibody ≥ 98%) groups occurred via KPD. Yet, the proportion of KPD transplants performed in sensitized recipients has declined since 2013, likely due to changes in the deceased donor allocation policies and newer KPD strategies such as compatible KPD. In 2021, 40% of the programs reported not performing any KPD transplants. Our study highlights the need for understanding barriers to pursuing and expanding KPD at the center level and the need for more detailed and accurate data collection at the national level.

"Kidney paired donation (KPD) is rapidly evolving and reshaping the landscape of living donor kidney transplantation (LDKT). Since the initial KPD transplants performed in the United States in 1999,1 the scope of KPD has expanded substantially. With the inclusion of nondirected donor,2 it has progressed from simple 2-way or multiple-way exchanges to nonsimultaneous kidney donor chains3 and, more recently, to advanced and voucher donations.4 Downstream from nondirected donors, chains often conclude with end-chain kidneys allocated to candidates on the deceased kidney donor waitlist without a living donor (LD).5 Historically used to overcome the barrier of ABO/human leukocyte antigens (HLA) incompatibility, KPD is being increasingly used by compatible donor-recipient pairs to obtain more suitable kidneys for the respective recipients.6 KPD programs can be single center or internal, regional, or national.7,8 The largest multicenter or national KPD programs in the United States are the National Kidney Registry,9 the Alliance for Paired Donation,10 the MatchGrid/Medsleuth program,11 and the program operated by the Organ Procurement and Transplantation Network (OPTN).12 While multicenter KPD often expands the pool of candidates to improve match possibilities, there are examples of very successful single-center programs."

What's ahead for U.S. organ allocation in the coming year

 Here's the December announcement from HRSA of their plans for reforming organ procurement and allocation this year.  

Organ Procurement and Transplantation Network (OPTN) Modernization Initiative. HRSA's approach to securing best-in-class expertise and an independent Board of Directors, December 2023 Updates

"At every step of the modernization process, HRSA has been committed to robust competition for the first-ever multi-vendor solicitations for OPTN contracts, and we were pleased that Congress supported our vision for fundamental reform through passage of the bipartisan Securing the U.S Organ Procurement and Transplantation Network Act. For more than a year, we have pursued a fundamental sea change in how the OPTN operates in order to improve the performance, transparency, independence, and accountability of this life-saving system for patients – the first time in the nearly 40-year history of this program that any Administration has advocated for this type of fundamental reform to break up the monopoly. Below is an update on the progress made to date and details regarding next steps. 

...

"A key element of HRSA’s OPTN Modernization Initiative is the President’s Fiscal Year 2024 Budget proposal to more than double investment in organ procurement and transplantation with a $36 million increase over Fiscal Year 2023 for a total of $67 million. In light of the uncertainty regarding full-year appropriations for Fiscal Year 2024, as well as the upcoming holidays and HRSA’s commitment to providing at least 60 days for potential bidders to respond to solicitations, HRSA plans to issue the solicitations in January 2024.

...

"1. Launching an Independent OPTN Board of Directors

"Current practice: For nearly 40 years, the Board of Directors for the Organ Procurement and Transplantation Network (OPTN) has been comprised of the same individuals who serve as the Board of Directors for the private entity that has held the OPTN contract. No formal requirements existed to protect against conflicts of interest resulting from this shared role.

"Under HRSA’s OPTN Modernization Initiative:

"HRSA will issue a solicitation in January 2024 for independent non-profit organizations to bid on supporting an independent OPTN Board of Directors in order to ensure mission-driven governance, strong conflict of interest policy, and that the system remains a public good not a private asset. The organization awarded the OPTN Board Support Contract will not be awarded any other OPTN contract.

...

"2. Robust Competition for First Ever Multi-Vendor Solicitations to Support Best-in-Class Vendors for OPTN IT, Operations, Communications, Research and Evaluation

"Current practice: Across the nearly 40-year history of the OPTN, all functions of the OPTN have been managed by a single vendor and not competed based on technical expertise in areas like IT or operations. This does not serve patients well and does not allow the system to keep pace with modern technology.  

"Under HRSA’s OPTN Modernization Initiative:

"Phase 1 — Competitive Transition Contracts:

"In January 2024, HRSA will release solicitations open to all non-profit and for-profit organizations for proposals for OPTN work related to information technology management, operations, data analytics/research, and communication.

"These contracts will support the transition from the legacy OPTN system to a modernized system and approach while ensuring uninterrupted access to the organ matching system and related processes in order to support transplantation and prevent unnecessary risk while protecting patients. As such, we refer to them as Competitive Transition Contracts.

...

"Phase 2 — Next Gen Contracts:

"In Summer 2024, HRSA will issue solicitations open to all non-profit and for-profit organizations for proposals for the OPTN Next Gen contracts.

"The Next Gen contracts will prioritize human-centered design practices and will focus on developing a truly modern organ matching technology solution that is highly reliable, secure, and user-friendly."

######

So the plan is to start this month with bids for contracts to manage the transition from the current system to the 'next generation' system, and to follow those in the summer with bids to design the next generation system. (If that seems out of order to you, you're not the only one.)

Waiting for HRSA's request for bids to reorganize deceased organ recovery and allocation

Frank McCormick's invaluable email newsletter includes this Bloomberg article on potential bidders who may emerge when HRSA puts out bids to break up the functions that UNOS presently aggregates for managing the deceased donor organ system.  I'm still not at all sure what bids will be forthcoming, especially since the planned request for bids is still quite opaque.

Big Tech, Startups Look to Revamp Troubled Organ Donation System  by Tony Pugh

"Later this fall, the Health Resources and Services Administration plans to solicit bids for the first round of contracts on the OPTN modernization project. The competition will usher in a years-long effort to both stand up new digital technology that better serves the 100,000-plus people on the organ waiting list, while increasing accountability, equity, and efficiency in the way organs are recovered, matched, and transplanted."

Often when I see a short quote broken up into even smaller pieces I worry that it might not accurately represent what was actually said, but this quote is spot on:

“When I look at” the current software used to match organs with possible recipients and to send accept-or-refuse offers to transplant surgeons, “it reminds me of the 1980s,” said Nobel Prize-winning Stanford University economist Alvin E. Roth, who studies how kidneys are matched with suitable candidates.

UNOS ends its liver exchange pilot program

UNOS has shuttered it's liver exchange pilot program, after less than a year, without having performed any liver exchange transplants. (My understanding is that this wasn't part of UNOS's OPTN contract, but part of its activities as a private company.)

A colleague forwarded me this announcement:

"After careful consideration and evaluation, we regret to announce the discontinuation of the UNOS Liver Paired Donation Pilot Program (LPDPP).

The UNOS LPDPP was launched with the noble goal of matching candidates in need of a liver transplant with living donors from across the United States. Top-tier transplant programs from around the country participated in the program, entering pairs to be matched for transplantation.

 Despite the enthusiasm and dedication of the UNOS LPDPP Steering Committee, participating hospitals, a visionary funder and UNOS Labs staff, we must acknowledge that the program faced significant challenges. Regrettably, no matches were made, and no transplants occurred during the course of the pilot.

 This decision to discontinue the program is a result of several factors, primarily the depletion of funding allocated to the pilot and other barriers to widespread adoption. While practical constraints have led us to this difficult decision, we are still committed to uncovering key insights that may help future efforts toward a national liver paired donation program and apply to other challenges facing the organ donation and transplant community.

 We would like to express our heartfelt gratitude to the Steering Committee, participating transplant programs’ staff, candidates and donors who agreed to be entered and the generous living liver recipient who funded this endeavor. Your dedication to saving lives through organ transplantation is truly commendable. These efforts have yielded valuable data and insights that will allow our community to continue to advance.

 While this chapter may be closing, our commitment to increasing the number of lives saved through organ donation and transplant remains unwavering. We will continue to explore innovative ways to improve access to organ transplants for those in need. We will be doing more investigation into the program’s barriers to success, unexpected challenges and opportunities for improvement, and we plan to share our discoveries with the community so we may all learn from the results.

 The program will officially end November 30, 2023, with the last match run on September 30, 2023."

###########

Earlier:

Friday, January 27, 2023

Liver exchange pilot program at UNOS

see also, from UNOS:

Liver paired donation — LPD

and this, from Medscape:

Can a Nationwide Liver Paired Donation Program Work?   by Lucy Hicks, January 30, 2023

"It is possible that the 1-year pilot program could run without performing any paired transplants, but that's unlikely if multiple pairs are enrolled in the system, the spokesperson said. At the time of this story's publication, the one enrolled pair are a mother and daughter who are registered at the UCHealth Transplant Center in Colorado.

...

"The pilot program requires that the donor bring one support person with them if they need to travel for the surgery, but undergoing major abdominal surgery from a transplant team they are not familiar with may be stressful, said Peter Abt, MD, a transplant " at the Hospital of the University of Pennsylvania and the Children's Hospital of Philadelphia. "That's a big ask," he said, "and I'm not sure many potential donors would be up to that."

"John Roberts, MD, a transplant surgeon at the University of California, San Francisco, agreed that the travel component may put additional stress on the donor, but "if it's the only way for the recipient to get a transplant, then the donor might be motivated," he added.

...

"Leishman agreed that the travel aspect appears to one of the greatest barriers to participants entering the program but noted that a goal of the pilot program is to understand better what works — and what doesn't — when considering a liver paired donation program on a national scale. "[Our] steering committee has put together a really nice framework that they think will work, but they know it's not perfect. We're going to have to tweak it along the way," she said."

The Cost of Inaction and the Urgent Need to Reform the U.S. Transplant System: participant statements

 Yesterday's Senate Finance committee hearings on The Cost of Inaction and the Urgent Need to Reform the U.S. Transplant System are on video, and the following witness statements (delivered beforehand) are now also available.

If you only have time to read one, I'd recommend clicking on the testimony of Matthew Wadsworth, the President And CEO of the OPO, Life Connection of Ohio.

Witnesses 

---

1. LaQuayia Goldring
   Patient
   Louisville , KY
   • Download Testimony
2. Molly J. McCarthy
   Vice Chair & Region 6 Patient Affairs Committee Representative
   Organ Procurement and Transplantation Network (OPTN)
   Redmond , WA
   • Download Testimony
3. Matthew Wadsworth
   President And CEO
   Life Connection of Ohio
   Kettering , OH
   • Download Testimony
4. Raymond J. Lynch, MD, MS, FACS
   Professor Of Surgery And Director Of Transplantation Quality And Outcomes
   Penn State Health Milton S. Hershey Medical Center
   Hershey , PA
   • Download Testimony
5. Donna R. Cryer, JD
   Founder And CEO
   Global Liver Institute
   Washington , DC

**********

Thursday, July 20, 2023

Senate Finance Subcommittee on Health Care --testimony on organ transplants, going on now

Senate Finance Subcommittee on Health Care --testimony on organ transplants, going on now

Watch right now or listen later.  UNOS is not popular in the Senate.

 https://www.c-span.org/video/?529461-1/health-advocates-testify-improving-organ-transplant-system

JULY 20, 2023

Health Advocates Testify on Improving Organ Transplant System

Patients and health professionals testify on the effectiveness of the organ transplant system before the Senate Finance Subcommittee on Health Care.

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Another set of links:Subcommittee Hearing

The Cost of Inaction and the Urgent Need to Reform the U.S. Transplant System

Subcommittee on Health CareDate: Thursday, July 20, 2023Time: 10:00 AMLocation: 215 Dirksen Senate Office Building

HRSA's Organ Procurement and Transplantation Network Modernization Initiative

 The Health Resources and Services Administration (HRSA) has announced a timeline for moving forward on the proposal to reorganize the system for obtaining and distribution deceased donor organs for transplant, aiming for a request for proposals in the Fall.

Organ Procurement and Transplantation Network Modernization Initiative   May 2023 Updates

"On March 22, 2023, the Health Resources and Services Administration (HRSA) announced a Modernization Initiative to strengthen accountability and transparency in the Organ Procurement and Transplantation Network (OPTN). The initiative is focused on five key areas: technology, data transparency, governance, operations, and quality improvement and innovation. As part of our commitment to transparency around the Modernization Initiative, HRSA is providing an update on our upcoming action steps.

The OPTN Modernization Initiative is centered on putting patients first, prioritizing information flow to clinicians, promoting innovation through continuous competition, and enhancing transparency and accountability. HRSA's planned approach and timelines for the first year of the multi-year modernization process focuses on design, implementation, and oversight, including contract solicitations that will be released Fall 2023 and Spring 2024. In addition, HRSA continues to pursue the legislative changes and increased funding included in the President's Fiscal Year 2024 budget to implement and advance the Modernization Initiative.

Summer 2023

Phase 1: OPTN Modernization Design & Strategy Development  

External Engagement and Design Planning Contract  – HRSA is currently conducting market research to inform the development of the upcoming Fall contract solicitations and will host an Industry Day for interested parties and vendors this Summer. Building on our outreach efforts over the past year, HRSA also will continue to ensure that patient, family, and clinician voices are engaged in this work, including through focus groups and other approaches. HRSA recently awarded a program management contract to support this stakeholder engagement as well as strategic and operational planning and change management.

Fall 2023

Phase 2A: OPTN Transition Management

HRSA recognizes the vital need to maintain uninterrupted access to the critical systems and functionality that support organ matching and transplantation during the modernization process. Working with the best technologists in the U.S. Government, HRSA expects to conduct this work on a dual track so that there are appropriate safeguards to ensure no disruptions in service as part of modernization implementation. Therefore, HRSA will support two significant multi-vendor solicitations between now and Spring 2024 – with the first solicitation to be issued this Fall 2023. This action will be followed by a Spring 2024 solicitation to further the next generation OPTN, as noted below. 

Competitive OPTN Transition Contracts – This Fall, HRSA plans to release a solicitation to establish new contracts that will support and enhance OPTN operations while the modernization process is underway. These contracts will ensure the continuation of critical OPTN support functions and enable appropriate upgrades on a parallel track with modernization. The Fall 2023 solicitation will seek multiple vendors for distinct functions – including supporting a separate OPTN Board of Directors – to ensure service continuity and increase oversight and accountability.

To ensure that the OPTN Transition contracts are developed in a way that meets the needs of all stakeholders, HRSA is committed to soliciting feedback from interested parties during the development and implementation of this work. By involving stakeholders in the process, HRSA can ensure that the Transition contracts advance the goals of the OPTN Modernization Initiative, provide optimal support to protect patient safety, and ensure the efficient functioning of the OPTN.

Spring 2024

Phase 2B: OPTN Modernization Implementation

In Spring 2024, HRSA intends to release a solicitation for multiple vendors to support the next generation of the OPTN, which will include enhancements in technology, governance, data transparency and operations. The separate Board of Directors contract and the deliverables from this next generation solicitation will form the foundation of a new, modernized OPTN. 

OPTN Next Generation Contracts – The proposed OPTN Next Generation contracts will represent a significant step forward in modernizing the OPTN’s foundational IT systems. In Spring 2024, HRSA expects to release a solicitation seeking multiple vendors for the OPTN Next Generation contracts to provide a comprehensive approach to modernizing the OPTN. The goal of this solicitation is to find contractors who will use innovative, best in class approaches to carrying out specific functions, including initial prototyping, testing, scaling, integration, deployment, and adoption support.  

HRSA is committed to transparency in the OPTN Modernization process and will continue to provide updates on our iterative approach toward achieving enhanced accountability, equity, and performance in the organ transplantation system, as appropriate, as this work moves forward."

***********

Here's a NYT story covering the announcement, with some background:

U.S. Organ Transplant System, Troubled by Long Wait Times, Faces an Overhaul The Biden administration announced a plan to modernize how patients are matched to organs, seeking to shorten wait times, address racial inequities and reduce deaths.  By Sheryl Gay Stolberg

Deceased-donor transplants: UNOS in the crosshairs

 There is unprecedented political will aiming towards reform of the system by which organs for transplant are recovered from deceased donors in the U.S. and allocated to patients in need of a transplant.  Here are two opposing views about current proposals to reform or replace the current government contractor in charge of this system, UNOS, the United Network for Organ Sharing..

From NPR:

The Government's Plan To Fix A Broken Organ Transplant System, March 28, 2023

You can listen here:

"For nearly 40 years, the United Network for Sharing Organs (UNOS) has controlled the organ transplant system.

"But that's about to change. Last week, the government announced plans to completely overhaul the system by breaking up the network's multi-decade monopoly.

"For those who need an organ transplant, the process is far from easy. On average, 17 people die each day awaiting transplants. More than 100,000 people are currently on the transplant waiting list according to the Health Resources and Services Administration.

"UNOS has been criticized for exacerbating the organ shortage. An investigation by the Senate Finance Committee released last year found that the organization lost, discarded, and failed to collect thousands of life-saving organs each year.

"Can the government reverse decades of damage by breaking up control? And what does this move mean for those whose lives are on the line?

"The Washington Post's Health and Medicine Reporter Lenny Bernstein, Federation of American Scientists Senior Fellow Jennifer Erickson, and Director at the Vanderbilt Transplant Center Dr. Seth Karp join us for the conversation. Dr. Karp was also a former board member for The United Network for Sharing Organs

*********

And here's an alternate view, by three professors of surgery at the University of California San Francisco Medical Center, saying that the system isn't badly broken at all, and that attempts to fix it may lead to coordination failures that, at least in the short term, will cause additional problems.

From MedPageToday:

Our Organ Transplant System Isn't the Failure It's Made Out to Be. — Upholding the system will save lives  by Peter G. Stock, MD, PhD, Nancy L. Ascher, MD, PhD, and John P. Roberts, MD, March 24, 2023

"Thanks to a robust network of hospitals, nonprofit organizations, and government support, the U.S. remains a leader in organ transplantation. This community, which is managed by United Network for Organ Sharing (UNOS), saves tens of thousands of lives every year. Despite this success, opponents of UNOS are advocating to dismantle the transplant system as we know it.

...

"As transplant surgeons with a long history of involvement with the system -- including one of us (Roberts) serving as a past Board President of UNOS/Organ Procurement and Transplantation Network (OPTN) -- we have intimate knowledge of both its successes and its shortcomings. While UNOS has room to improve operationally -- and is working to do so -- we clearly see the organization's life-changing results in our operating rooms and offices. More work lies ahead, however, such as addressing the fact that a rising number of organs are recovered but not transplanted.

"Neither UNOS nor organ procurement organizations (OPOs), which facilitate recovery and organ offers to hospitals, have control over whether medical centers ultimately accept and transplant organs into patients. Though the former two have taken all the blame to date, this remains an issue that concerns the entire system. Leaving our nation's transplant centers out of this critical discussion is a serious oversight. For our entire system to save more lives, transplant centers need to have clear organ acceptance criteria, the appropriate resources to process available organs, and the tools and flexibility to utilize organs from more medically complex donors.

...

"The recommendations for division of labor as suggested this week by Carole Johnson, administrator of the Health Resources and Services Administration (HRSA), may be well intentioned but present a significant risk of further fragmentation and negative consequences due to a lack of coordination between government agencies and contractors. This coordination is essential for a functional and successful system. UNOS specifically has been handicapped by a meager budget for years, and despite this has a well-developed system. We believe that given the recent 10-fold budget increase by the Biden administration, the current contractor has the potential to rectify the shortcomings that have been highlighted in the press."

*********

Earlier posts:

Sunday, August 14, 2022

More on UNOS in the hot seat and calls for reform of the U.S. deceased donor transplant system

Thursday, March 23, 2023

Health Resources and Services Administration (HRSA) Announces Organ Procurement and Transplantation Network Modernization Initiative.