ASN Transplant Policy Committee Advocates for Maximizing Transplant Access

KN: Last year, the Health Resources and Services Administration (HRSA) released for public comment a proposed expansion of the Organ Procurement and Transplantation Network (OPTN) data collection to include pre-waitlist data for all patients with solid organ transplants. The committee submitted feedback and published your thoughts (1). What do pre-waitlist data constitute?

Patzer: [Pre-waitlist data include] any step occurring prior to when a patient is placed on the national waiting list, including referral and evaluation for transplant. Typically, there is a referral form that has to go from their physician to the transplant center; that date of referral, any information about the patient at the time of referral, and aspects of the evaluation are considered part of pre-waitlisting data.

Once the patient is referred by their clinician, typically a nephrologist, they then start the evaluation process at the transplant center. That process varies by transplant center but typically includes education, a financial evaluation, a psychosocial evaluation, and a medical evaluation. Usually, the patient goes through multiple appointments before a multidisciplinary team determines transplant eligibility at the waitlist selection conference. All of these steps are considered pre-waitlisting steps.

KN: How will it be helpful to have that information?

Patzer: For so long, we haven't understood the true demand for transplant because existing national surveillance data only capture data on patients placed on the waiting list. There are patients who were referred and did not start the evaluation or patients who started the evaluation but did not complete it, but we don't know—it's a black box. There's a lot in terms of quality improvement that a transplant center, the referring physician, or the dialysis facility might want to do to improve access to transplant. But if we don't know what's going on in the black box of waitlisting, it's really challenging to do that.

For example, research has shown that barriers to getting a transplant may be different than barriers to getting placed on the waiting list, which may be different than the barriers to even starting the evaluation. It's challenging to try to intervene or address those issues unless we know, for a particular patient population or region, what the specific challenges are. Is it that they have high rates of referral but low rates of starting the evaluation? That might tell us that we need to look more at the transplant center process. If they have high rates of starting the evaluation but low rates of listing, that might tell us that we need to focus on a different part of the process. We’ve seen so much research around variation in access to some of these early transplant steps that we know there's substantial variation in practice. We don't have national data on this now, but we’ve looked at this in the southeast, primarily in Georgia, North Carolina, South Carolina, and other regions—and other researchers have done this in smaller-scale studies—and found that there are a lot of inequities in access or variation in access at the transplant center level or dialysis facility level that we really need to understand before we can address the issues.

Mohan: More than half a million people are on dialysis, but the proportion of patients on the waitlist is decreasing, so access to the transplant waitlist is actually decreasing. We don't fully understand why. Rachel's work has shown very clearly that access to the waitlist varies. As a patient, you may go to one transplant center and get declined as a candidate for waitlisting, but if you go to another center, that other center may actually accept you as a candidate. That variation is significant, and we don't fully understand the reasons for it. Patients have no visibility of that process, so if we want to change access to transplant, we have to change access to the waitlist. And if we want to change access to the waitlist, we have to know why people are not making it onto the list. Is it because people aren't being referred, or is it because centers have different thresholds?

KN: In your comments to HRSA, you supported this data collection but recommended a phased-in approach. Can you elaborate?

Patzer: This is a significant change in data collection, and that does have a potential burden on transplant centers. So, we recommended a potential phased-in approach to collecting that data, in which submission might be voluntary for a certain period of time. We don't know how this will be rolled out. HRSA announced this directive and solicited one round of public comments, but there hasn't yet been the second round of public comments, so it's not entirely clear what implementation may look like. We don't know what's going to happen, but it's important to recognize that this is a potential unfunded mandate. HRSA did recommend it being paired with removing some data elements and forms at the same time.

Mohan: There's reluctance from some quarters in the transplant community about collecting more data, and a hesitation that these are data that are going to inform research but create a burden on transplant centers. It's important to emphasize that this is not research data, and the proposed collection approach is cognizant of the current data burden. We proposed using data that already exist in the electronic medical record and a collection approach that is less time and resource intensive because it's batched data reporting. We’re starting with the most basic critical elements that we think will give us at least some understanding of what is happening. This will evolve and be informed by what we learn. So, if we learn that there's a lot of variation in evaluation time, then we may want more granular data to understand why there is so much variation. But as a first step, we need to understand, after people are referred to a transplant center, how many people start an evaluation or how many people finish. We only know how many people make it onto the waitlist.

KN: What is the status? When could a final decision be rendered?

Patzer: We are in a little bit of a wait-and-see pattern for next steps from HRSA. HRSA is going through all of the public comments that it received by early January and then will put forward more specific information and ask for public comment one more time—this time with a 30-day time period. After that, we’ll have more details of when and how this will be implemented, and what specific data elements will be included. The ASN Transplant Policy Committee has advocated for this. This workgroup that was actually part of OPTN had all of these recommendations for how this should work and what data elements should be collected. There's a lot going on at the federal government, so it is possible that HRSA may hold off on this last public comment period for a little bit longer, until things settle.

Mohan: We haven't heard anything from HRSA on this front, although the next step is another comment period from the Office of Management and Budget before it's formally implemented by OPTN. It's unclear to what extent the current proposals for data elements or the collection cadence will change during the process prior to implementation, so it's clearly a wait and see for now.

KN: What are some of the barriers that would need to be overcome for this to happen successfully? You mentioned technology as one hurdle.

Patzer: The OPTN Modernization Initiative calls for modernizing the transplant data system. There's a lot that we could do to improve data collection processes to reduce that burden. Unfortunately, we don't know all of the specifics of the OPTN Modernization Initiative, including specific task orders and priorities for technology. The potential barriers are slower rollout of modernizing the data system, so if we’re relying on antiquated ways to collect these data, that does cause more burden on transplant center staff. It comes down to time and staff, and transplant centers will bear the brunt of that.

Other potential barriers are that people may not understand the value of how these data could be used, since they’re newer data elements. There's a lot we need to do to educate our community about that value. The Transplant Policy Committee has been trying to focus on how this is really beneficial, primarily for patients and their families. It's also been called for by experts in the field for many years. Collecting pre-waitlisting data is named in the NASEM (National Academies of Science, Engineering, and Medicine) report for more transparency in this process. Patients want to know where the best place is for them to get a transplant or to get on the list, and these data would help inform that decision.

Mohan: Transplant centers have to be willing to do this. There's some misunderstanding in the community about what the goals are and why this would help. It's important that people understand that this is valuable for patients and valuable for us to evaluate the underlying need. For kidney diseases, we have a population with kidney failure, so we have some sense of what the needs are or the scope of the problem. In the other organ transplant systems, there's no denominator. We have no idea how many patients with cirrhosis or how many patients with heart failure exist out there with end-stage heart failure who would benefit from a heart transplant. The waitlisting data proposal is organ-agnostic, so it would actually help us develop a better sense, for the first time, of what the transplant need is in all of the other organ systems, which is information that's been lacking.

KN: What else are you actively working on?

Patzer: One main priority is coordinating with other ASN committees. I serve as the liaison between the Transplant Policy Committee and the ASN Policy and Advocacy Committee, forming collaborative relationships to shape transplant policy, helping our members understand what implementation might look like and understand how transplant-related policies might impact their practices, and then trying to increase access to donor kidneys as well. If I were to brainstorm what we think they’re going to be, it's things like focusing on the Center for Medicare & Medicaid Services’ (CMS’) Increasing Organ Transplant Access (IOTA) model and building awareness around it. Last year, we spent a lot of time trying to get more resources around implementation for the OPTN Modernization Initiative, so we’ll be closely following that as well. The pre-waitlisting data will be another priority of ours, ensuring that implementation of this policy moves forward.

Mohan: I think there's also going to be an increased focus on allocation policy because of the ongoing rise in out-of-sequence kidney allocation (2). I’m hoping that will be a major focus so that we can figure out that piece. At the end of last year, HRSA put a stop to all out-of-sequence allocation work from the Expeditious Task Force, but that hasn't stopped the practice. We’re waiting to see what it looks like.

KN: IOTA will start this July. What do you expect we will see or learn from that?

Mohan: CMS has randomized half of the country into the IOTA model. There are 103 transplant centers that are in it, and they’re all incentivized to grow volume-wise. What I expect to see is that those centers will really grow. In fact, between 2023 and 2024, there was essentially no increase in the number of kidney transplants that happened year over year. Hopefully that will change. That's one goal. The other goal is allocation efficiency. If they are able to move the needle on allocation efficiency, as measured by a higher organ offer acceptance rate, we should see fewer discarded organs and more effective organ allocation.

Patzer: We’re not going to see major results yet, but all of the transplant centers that were allocated or randomized to be in the model are starting to have a lot of conversations and thinking about what they could be doing right now to prepare for this.

KN: If you could implement a single change in transplant policy tomorrow, what would it be?

Mohan: A better allocation system. I think our allocation system is the root cause of many of the challenges in transplantation today. If there is something we could change more quickly, it would be much more transparency. There needs to be transparency in terms of how centers accept or list patients and how centers accept organs or don't. Not having that transparency has allowed centers to become selective in terms of which patients they accept for waitlisting and which organs they’re willing to accept, to the detriment of patient access to transplant and presumably to patient outcomes.

Patzer: I’m going to come at it from the data side, which is having one system in which all of these data live, and there is real-time access to that data, and it's interoperable, and it's standardized, so that we didn't spend so much time and effort chasing it. It's pie in the sky, a little bit, but it is technically feasible.

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