Government Plans Overhaul of Organ Transplant Network

Restructuring an archaic system

The IT portion is the function mentioned most that could be separated between UNOS and the OPTN. Separating IT would be in agreement with a recommendation from a National Academies of Sciences, Engineering, and Medicine study, “Realizing the Promise of Equity in the Organ Transplantation System” (1), published last year, as well as a recommendation from the U.S. Digital Service, a government agency dedicated to improving government services through technology modernization and data science. In July 2022, The Washington Post reported that a confidential assessment by the U.S. Digital Service designated the UNOS technological system archaic and recommended it be “vastly restructured” (2).

Kidney community leaders have been making this point for years, with the ASN statement noting that separating the OPTN contract into distinct pieces that can be bid on by multiple entities would align the contract with federal contracting protocols, increase competition, and drive innovation. “There is a sense in the community that the existing information technology is outdated, and it could better serve patients if it were operated by a contracting entity with a more specific focus on technology and IT expertise,” Meyer said.

“UNOS has not invested adequately in the resources,” said Mohan, who also chairs the UNOS Data Advisory Committee. “If you don't invest in the resources, you end up with an archaic system that has not moved much in the last 20 years.” He said the UNOS systems are based on a programming language that is “years and years old and hasn't really progressed.”

Mohan explained that one example of the difficulty in improving UNOS's system was the long, drawn-out process of introducing new codes to transplant centers to specify why they declined to use a kidney for transplant. That process—which involved creating a single, pull-down menu—took nearly 5 years.

Another oft-cited source of frustration is the difficulty in tracking kidneys procured for transplant. “You have the ability to track any package that you have ordered on Amazon and know approximately where it is at any given point in time,” Mohan said. “The fact that UNOS has never looked at creating a GPS [global positioning system] tracking system for organs underscores the lack of desire to make progress.”

UNOS' management of transplant waiting lists is another common target of complaint. “The waitlists are often poorly curated and maintained due to insufficient communication among transplant centers, dialysis facilities, and patients or their care partners. As a result, nearly one in five kidneys is now offered to a deceased person still on the waitlist because the transplant center is unaware that the patient is deceased,” ASN's Past President Susan E. Quaggin, MD, FASN, wrote in a letter to the HRSA in response to a request for information on improving the OPTN (3).

ASN Quality Committee Chair Scott Bieber, DO, told ASN Kidney News that as a general nephrologist practicing in rural, northern Idaho, he and his patients “struggle with the lack of transparency in the transplant program. It has been opaque to us as to what the transplant programs expect from patients. They are not consistent or clear about what it takes for a patient to get onto the transplant list. Certain patients are able to navigate the system fairly easily, and others really struggle or don't have the resources to make it happen.”

Even for patients who make it onto the list, “as a referring nephrologist and as a patient, you are kept in the dark. You don't have any clue where you are on the list and you are never told if an organ is offered or if the transplant system has bypassed you,” Bieber said. Mohan noted that in most health systems, patients can access current information through a program like MyChart, but nothing like that exists for transplant patients.

The HRSA announcement promised to increase transparency through the introduction of “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.” Representatives of the agency said that it started the process of upgrading OPTN IT last year by engaging the U.S. Digital Service to leverage its expertise and advice in implementing the modernization initiative.

As part of its announcement, HRSA unveiled “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 [these] data to inform decision-making. Today's launch is an initial data set, which HRSA intends to refine over time and update regularly.” The dashboard can be found at https://data.hrsa.gov/topics/health-systems/organ-donation.

Increased funding

Upgrading IT will cost money, and the HRSA announcement also noted that the Biden administration's fiscal year 2024 budget request would more than double federal investment in organ procurement and transplantation. The $36 million increase over the previous year would bring the total to $67 million. The administration is also requesting Congress to update the National Organ Transplant Act of 1984 to remove the appropriations cap on OPTN contracts and to expand the pool of eligible contractors to increase competition. The National Organ Transplant Act currently places constraints on HRSA, but in an interview with The Washington Post, HRSA Administrator Carole Johnson said that HRSA has the legal authority to move forward even without congressional action. She said that bid solicitations could go out as soon as this fall (4).

Congress has already begun to move to support HRSA's efforts. On April 10, Rep. Larry Bucshon, MD (R-Ind.), and Rep. Robin Kelly (D-Ill.) said they had introduced legislation that would allow HRSA to “run a competitive process to choose the best contractors for different national OPTN functions (e.g., health IT and logistics).”

Whether Congress will agree to such an increase in spending is anyone's guess at a time when the Republican leaders in the House of Representatives say they will not increase the debt ceiling without as-yet unspecified budget cuts. “We know that this is going to be a very challenging year for appropriations,” said ASN's Meyer. “It remains to be seen how much of the $67 million request will be granted by Congress and the extent to which the funding will allow HRSA to fully realize the promise of the reforms it announced. ASN will be working with Congress on a bipartisan basis to ensure that [lawmakers] understand how important these changes are, and kidney transplantation has enjoyed a lot of bipartisan support in recent years.”

Bipartisan support

That bipartisan support was evident in statements praising the HRSA announcement from Sen. Ron Wyden (D-Ore.) and Sen. Chuck Grassley (R-Iowa), the chair and past chair, respectively, of the Senate Finance Committee, who have collaborated on hearings on and investigations into the OPTN.

“[HRSA's] announcement is a big victory for families across the country who have been fighting for a more effective organ procurement and transplantation system,” Wyden said. “For too long it's been clear that UNOS has fallen short of the requirements for this contract and the expectations of Americans waiting for a transplant.” Wyden's statement said HRSA's “intent to issue multiple contracts for the OPTN contract” is “an important step towards breaking up a longstanding monopoly contract held by UNOS.” Grassley added that “The U.S. transplant network has failed at all levels, putting lives at risk, wasting valuable life-saving organs, and [disproportionately] affecting people of color and those living in rural America. Today's announcement is welcome news after years of uncovering troubling trends in our nation's organ procurement programs.”

The drive for more funding could receive a boost from a 2020 report from the Senate Finance Committee that said: “Experts also project that improvements to the OPTN could save the federal government and taxpayers up to $40 billion over the next decade, particularly through reductions in dialysis and treatment of End Stage Renal Disease, which accounts for $36 billion in Medicare spending each year.”

UNOS response

For its part, UNOS responded that it “supports HRSA's plan to introduce additional reforms into the nation's organ donation and transplantation system. We also stand united with HRSA in our shared goal to get as many donor organs as possible to patients in need while increasing accountability, transparency, and oversight. We welcome a competitive and open bidding process for the next OPTN contract…. We believe we have the experience and expertise required to best serve the nation's patients and to help implement HRSA's proposed initiatives.”

As previously noted, the NKF joined ASN in welcoming the initiative. “Our current transplant system still relies on antiquated technology and inefficient systems that create life-threatening bureaucracy and delays,” Longino said. “HRSA's move to redesign the OPTN contract will allow leaders in technology, artificial intelligence, supply chain management, and other critical business operations to bring their ideas and talent to a system that is in desperate need of reform.” He noted that the NKF has advocated for several years on the need to modernize the IT infrastructure, install an OPTN board of directors independent of UNOS, and develop a public dashboard of key measures.

ASN President Josephson said: “Ensuring OPTN's technology systems are fully modernized and leveraging their capabilities is a foundational step to improving the transparency and efficiency of the kidney health ecosystem and is a prerequisite to achieving ASN's goal of maximizing access to kidney transplantation. I applaud HRSA's public commitment to building that capacity and ensuring future systems better serve the needs of patients and their families.”