Thursday, March 23, 2023

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

Here's a long awaited HRSA announcement, indicating their intent to modernize the deceased organ procurement and allocation system in the U.S.  It's still a bit short on details, but specifically mentions budget increases. In the future it will apparently issue Requests for Proposals from organizations willing to bid on parts of the transplantation allocation system, including software. (I hope HRSA is also thinking about how organ allocation policies will be revised and kept up to date in the future, including the possibility of experimenting with proposed improvements on a regular basis.)

The press release:

HRSA Announces Organ Procurement and Transplantation Network Modernization Initiative. Initiative includes the release of new organ donor and transplant data; prioritization of modernization of the OPTN IT system; and call for Congress to make specific reforms in the National Organ Transplant Act

"[March 22, 2023] Today, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), announced a Modernization Initiative that includes several actions to strengthen accountability and transparency in the Organ Procurement and Transplantation Network (OPTN):

"Data dashboards detailing individual transplant center and organ procurement organization data on organ retrieval, waitlist outcomes, and transplants, and demographic data on organ donation and transplant;

"Modernization of the OPTN IT system in line with industry-leading standards, improving OPTN governance, and increasing transparency and accountability in the system to better serve the needs of patients and families;

"HRSA’s intent to issue contract solicitations for multiple awards to manage the OPTN in order to foster competition and ensure OPTN Board of Directors’ independence;

"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; and,

"A request to Congress included in the Fiscal Year 2024 Budget to update the nearly 40-year-old National Organ Transplant Act to take actions such as:

"Removing the appropriations cap on the OPTN contract(s) to allow HRSA to better allocate resources and,

"Expanding the pool of eligible contract entities to enhance performance and innovation through increased competition.

“Every day, patients and families across the United States rely on the Organ Procurement and Transplantation Network to save the lives of their loved ones who experience organ failure,” said Carole Johnson, HRSA Administrator. “At HRSA, our stewardship and oversight of this vital work is a top priority. That is why we are taking action to both bring greater transparency to the system and to reform and modernize the OPTN. The individuals and families that depend on this life-saving work deserve no less.”


"Today, HRSA is posting on its web site at Organ Donation and Transplantation (hrsa.gov) a new data dashboard to share de-identified information on organ donors, organ procurement, transplant waitlists, and transplant recipients. Patients, families, clinicians, researchers, and others can use this data to inform decision-making as well as process improvements. Today’s launch is an initial data set, which HRSA intends to refine over time and update regularly.

"This announcement also includes a plan to strengthen accountability, equity, and performance in the organ donation and transplantation system. This iterative plan will specifically focus on five key areas: technology; data transparency; governance; operations; and quality improvement and innovation. In implementing this plan, HRSA intends to issue contract solicitations for multiple awards to manage and improve the OPTN. HRSA also intends to further the OPTN Board of Directors’ independence through the contracting process and the use of multiple contracts. Ensuring robust competition in every industry is a key priority of the Biden-Harris Administration and will help meet the OPTN Modernization Initiative’s goals of promoting innovation and the best quality of service for patients.

"Finally, the President’s Budget for Fiscal Year 2024 would more than double HRSA’s budget for organ-related work, including OPTN contracting and the implementation of the modernization initiative, to total $67 million. In addition, the Budget requests statutory changes to the National Organ Transplant Act to remove the decades old ceiling on the amount of appropriated funding that can be awarded to the statutorily required vendor(s) for the OPTN. It also requests that Congress expand the pool of eligible contract entities to enhance performance and innovation through increased competition, particularly with respect to information technology vendors.

"HRSA recognizes that while modernization work is complex, the integrity of the organ matching process is paramount and cannot be disrupted. That is why HRSA’s work will be guided by and centered around several key priorities, including the urgent needs of the more than 100,000 individuals and their families awaiting transplant; the 24/7 life-saving nature of the system; and patient safety and health. HRSA intends to engage with a wide and diverse group of stakeholders early and often to ensure a human-centered design approach that reflects pressing areas of need and ensuring experiences by system users like patients are addressed first. As a part of this commitment, HRSA has created an OPTN Modernization Website at OPTN Modernization (hrsa.gov) to keep stakeholders informed about the Modernization Initiative and provide regular progress updates."

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Here's a related story in the NY Times:

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

"The Biden administration announced on Wednesday that it would seek to break up the network that has long run the nation’s organ transplant system, as part of a broader modernization effort intended to shorten wait times, address racial inequities and reduce the number of patients who die while waiting.

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 Earlier, the Washington Post had a story about how the most recent (current) version of the system  for allocating deceased donors is indeed having some problems, the most serious of which (in my view) is the congestion  involved in placing an organ for transplant. (This congestion involves time in getting an organ accepted, and then transported...)

New liver transplant rules yield winners, losers as wasted organs reach record high. The number of lifesaving liver transplants has plummeted in some Southern and Midwestern states that struggle with higher death rates from liver disease  By Malena Carollo and Ben Tanen

"New rules requiring donated livers to be offered for transplant hundreds of miles away have benefited patients in New York, California and more than a dozen other states at the expense of patients in mostly poorer states with higher death rates from liver disease, a data analysis by The Washington Post and the Markup has found.

"The shift was implemented in 2020 to prioritize the sickest patients on waitlists no matter where they live. While it has succeeded in that goal, it also has borne out the fears of critics who warned the change would reduce the number of surgeries and increase deaths in areas that already lagged behind the nation overall in health-care access.

...

"The new system, called the “acuity circles” policy, has nearly doubled the median distance livers are transported, increased transport costs and coincided with the highest number of wasted livers in nearly a decade, 949 in 2021. That’s 1 in 10 donated livers. The analysis further shows a significant increase in the number of states sending donated livers beyond their own borders. In 2019, before the new policy took effect, 21 states and territories exported a majority of livers they collected. Two years later, 42 did."

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