Comments

Attleheide Anne Hoyt | 09/19/2023

Our population needs considerations for decreased restrictions on organ attainment for candidates, helping to make a quicker time response opportunity.

American Society of Nephrology | 09/19/2023

Dear Dr. Rudow and Dr. Lunz:

On behalf of the more than 37,000,000 Americans living with kidney diseases and the 21,000 nephrologists, scientists, and other kidney health care professionals who comprise the American Society of Nephrology (ASN), thank you for the opportunity to respond to provide comment regarding the Organ Procurement and Transplantation Network (OPTN) proposal “Remove CPRA 99-100% Form for Highly Sensitized Candidates.”

ASN supports the proposal to lift the existing requirement for transplant hospital to submit additional documentation for kidney candidates whose calculated panel reactive antibodies (CPRA) score is 99-100% for in order for these candidates to gain allocation priority.

As the proposal outlines, requiring both the transplant surgeon or physician and the Human Leukocyte Antigen (HLA) histocompatibility lab director to sign the form contributes to unnecessary delays in listing for these highly sensitized patients—and for some patients, missed opportunities to receive a kidney transplant. The data presented showing a median time of nearly seven days for the required signatures to be entered in the OPTN computer system demonstrates that this well-intentioned policy has had the unintended consequence of increasing the time highly sensitized patients must wait before they can begin receiving offers. Removing this administrative burden will reduce the chance that a highly sensitized candidate will miss the opportunity to be matched with an offer from a suitable donor.

ASN also supports the proposed approach to post-implementation monitoring. As the proposal outlines, no evidence exists that the system has been “gamed” by artificially reporting increased CPRA score. Moving forward, because any data entered in the OPTN computer systems may be reviewed by the OPTN, and because members are required to provide documentation as requested, ASN concurs that OPTN has ample ability to continue to ensure that programs continue to comply with this policy.

In sum, ASN appreciates OPTN’s and the committee’s dedication to ensuring that no patients face unnecessary administrative delays in waitlisting due to their sensitization status. The society encourages OPTN to finalize this proposal. Please contact ASN Strategic Policy Advisor Rachel Meyer at rmeyer@asn-online.org with any questions or to discuss this letter in more detail.

Sincerely,

Michelle A. Josephson, MD, FASN

President

View attachment from American Society of Nephrology

Region 8 | 09/19/2023

Sentiment: 12 strongly support, 2 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose

This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. A member commented that they strongly support removing this administrative task in listing highly sensitized candidates. Another member suggested some form of periodic audit. 

Association of Organ Procurements Organizations | 09/19/2023

AOPO strongly supports the OPTN’s proposal to remove the CPRA 99-100% form for highly sensitized kidney candidates which requires a candidate’s HLA lab director and transplant physician or surgeon to review and sign a written approval of candidates’ unacceptable antigens for CPRA 99-100% candidates to gain allocation priority. This policy was developed out of a fear that transplant professionals would try to exploit the allocation system by falsely adding or “overcalling” unacceptable antigens into UNET to raise a patient’s CPRA percentage and obtain additional allocation points. However, the logic behind the policy is flawed because falsely reported unacceptable antigens have the effect of screening out potential donors for kidney candidates which calls into question whether the extra points conferred for highly sensitized candidates confer a true allocation advantage. Further, the current policy inexplicably assumes nefarious action by transplant professionals to assist kidney candidates in gaining allocation priority while a similar certification policy does not apply to liver, heart, or lung candidates, although manipulable lab results are also used to determine the waitlist status of these candidates.

Additionally, the CPRA form requirement for sensitized kidney candidates creates another administrative task for the few HLA lab directors in the nation who are tasked with serving a vast number of stakeholders under extremely tight turnaround times. The completion of the CPRA 99-100% form needlessly imposes more work on busy lab directors and physicians whose time is better served effectuating organ transplants than completing confirmatory paperwork that is vulnerable to the same human manipulation it seeks to eradicate (because lab directors and physicians can merely certify their own incorrect results). This superfluous paperwork can accumulate in a lab director’s or transplant physician’s UNET queue without being reviewed immediately which has the effect of delaying a candidate’s ability to gain allocation priority. Even more egregious is the fact that kidney candidates are often unaware of this administrative requirement and may be delayed allocation priority and opportunities for transplant without their knowledge and without recourse to capture the lost time as a priority candidate.

Finally, the OPTN’s proposed removal of the CPRA 99-100% form is appropriate because section 4.3 of the OPTN’s Histocompatibility Policy already requires laboratories to ensure “that all HLA typing is accurately determined and report HLA typing results to the OPO or Transplant Program according to the deadlines specified in the written agreement between the laboratory and the OPO or transplant

program.” In addition, the OPTN Bylaws specifically outline all mandatory elements of the written agreement required between histocompatibility laboratories and transplant programs which includes, “a process for reporting and verifying HLA and unacceptable antigen data at the time of registration on the waiting list and any time there are changes.”¹ Because the CPRA 99-100% form for highly sensitized kidney candidates is an ineffective safeguard, unnecessary administrative hurdle, and may serve as a delay or impediment to transplant for highly sensitized kidney candidates, AOPO supports its removal as a requirement under the OPTN histocompatibility policy.

 1 OPTN Bylaws, Appendix C.2C(4) https://optn.transplant.hrsa.gov/media/lgbbmahi/optn_bylaws.pdf

 

National Kidney Foundation | 09/19/2023

Attachment

View attachment from National Kidney Foundation

Region 9 | 09/19/2023

Sentiment: 4 strongly support, 6 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose

This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. A member stated that this form serves no good purpose and only makes the listing process more cumbersome. 

Region 3 | 09/19/2023

Sentiment: 4 strongly support, 10 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose

Region 10 | 09/19/2023

Sentiment: 8 strongly support, 5 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose

This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. One attendee noted that this change will save transplant programs time when adding patients to the waitlist.  

UC San Diego Health | 09/19/2023

The UC San Diego Health Center for Transplantation strongly supports the OPTN Histocompatibility Committee’s proposal to remove the administrative requirement to obtain signatures from both the HLA lab director and transplant surgeon or physician before a highly sensitized kidney candidate is eligible for a higher allocation priority. While we appreciate the Committee’s diligence in initially crafting policy requirements which promote compliance, we agree that in the absence of abuse, this form is not only no longer necessary but should be abolished promptly in light of evidence and operational experience that the process inadvertently delays candidates in receiving offers.

We are confident that maintaining the requirement that laboratories review and verify OPTN Waiting List HLA data, including the unacceptable antigens listed for a transplant candidate, and retain source documents (testing results) in accordance with applicable federal and state law, is sufficient. If there is a need to ensure compliance and accuracy of the reported CPRA, this could be added as an additional data element reviewed during routine triennial surveys.

With regards to the additional feedback solicited by the Committee, the team at UC San Diego Health offers the following:

• Transplant candidates could benefit from additional educational resources regarding the impact of CPRA on waiting time and would appreciate the Committee developing such materials.

• The Committee should consider removing the requirement programs complete the heart-kidney, lung-kidney and liver kidney eligibility confirmation forms. Data demonstrating recipients met this criterion is documented in the medical record and source documentation is currently audited during the triennial surveys for liver-kidney recipients; we anticipate compliance monitoring will expand to include heart-kidney and lung-kidney transplant recipients as well. We fail to see the benefit of transcribing information from these source documents both into the waitlist and onto a UNOS form that is simply stored in the medical record until audit time. It does however, create unnecessary additional administrative burden.

OPTN Kidney Transplantation Committee | 09/18/2023

The OPTN Kidney Committee thanks the OPTN Histocompatibility Committee for the opportunity to provide a public comment on the proposal. The Committee supports the proposal and further comments removing this requirement will reduce time to activation and increase exposure to potential organ offers for a candidate population that are already significantly disadvantaged.

Region 7 | 09/18/2023

Sentiment: 7 strongly support, 5 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose

This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. One attendee stated that administrative burdens should be removed if they do not add any benefit to the process. Another attendee added that the current form is unnecessary and seems to add delays to patient access. Lastly, it was noted that current efforts are trying to increase priority for these difficult to transplant candidates.

Banner University Medical Center - Phoenix | 09/18/2023

Per feedback from the clinical team this form puts an unnecessary administrative burden on the team and makes little difference in the outcome. In the outpatient setting tracking paperwork and awaiting for physicians to sign documents day to day is difficult. By eliminating this step it will allow patients to start accumulating their points sooner

American Society of Transplant Surgeons | 09/18/2023

See attachment.

View attachment from American Society of Transplant Surgeons

Gift of Life Michigan | 09/15/2023

We support the removal of this form. While it may have served a purpose at its inception, it seems possible at this point that the burden of obtaining signatures could adversely affect a patient’s wait time calculations with no discernible benefit.

Region 1 | 09/15/2023

Sentiment: 0 strongly support, 4 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose

Region 6 | 09/15/2023

Sentiment: 3 strongly support, 6 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose 

This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. One attendee supported the proposal commenting that the form is an extra administrative burden while adding little to clinical practice or patient safety.

American Society of Transplantation | 09/15/2023

The American Society of Transplantation (AST) generally supports the proposal, “Remove CPRA 99-100% Form for Highly Sensitized Candidates,” and offers the following comments for consideration:

• While the AST appreciates the Committee’s diligence in initially crafting policy requirements which promote compliance, we agree that in the absence of abuse this form is no longer necessary and should be abolished promptly considering the evidence the process may inadvertently delay candidates receiving offers.

• The AST believes maintaining the requirement that laboratories review and verify OPTN waiting list HLA data, including the unacceptable antigens listed for a candidate and retaining source documents (testing results) in accordance with applicable federal and state law, is sufficient. If there is a need to ensure compliance and accuracy of CPRA, this could be added as an additional data element that is reviewed during routine triennial surveys.

• Regarding other barriers highly sensitized patients may face, listing of allele-specific unacceptable antigens for highly sensitized candidates remains problematic. Because most donor typing is at the serologic antigen level, the match run often makes incompatible offers to these candidates. Highly sensitized patients are disadvantaged when centers choose to list antigen-level unacceptables to manage this issue, when only allele-specific unacceptables are justified by the antibody screening data. Thus, the burden on transplant centers of HLA-incompatible offers that must be refused through virtual crossmatch analysis remains a barrier to listing.

• The AST recommends continued monitoring and revisiting of data six months after implementation to assure that there isn’t an impact in access or equity.

View attachment from American Society of Transplantation

American Society for Histocompatibility and Immunogenetics | 09/14/2023

The American Society for Histocompatibility (ASHI) and its National Clinical Affairs Committee (NCAC) appreciate the opportunity to provide feedback regarding the removal of the form for highly sensitized kidney candidates. ASHI supports this proposal as it increases efficiency by reducing delays in getting both signatures prior to allotting appropriate points to highly sensitized patients. Written agreements between Histocompatibility Laboratory and Transplant programs describe requirements for listing unacceptable antigens and serve as sufficient documentation of practice for the program.

View attachment from American Society for Histocompatibility and Immunogenetics

Region 5 | 09/13/2023

Sentiment: 8 strongly support, 12 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose

An attendee supported removal of the CPRA 99-100% form for highly sensitized kidney candidates because the form’s intent and utility in clinical practice does not align. There are already standards in place that HLA data entered into UNOS is reviewed and verified.

Anonymous | 09/12/2023

I strongly support of eliminating this huge administrative burden that has been put in place with no apparent benefit/value to the transplant community, patient access or transplant safety. This requirement has likely resulted in a waste of tens of thousands of hours of extra work to the transplant professionals since its inception years ago.

More importantly, the overwhelmingly supportive feedback of eliminating this unnecessary requirement perhaps reveals the lack of transparency and adequate engagement with the transplant community when it comes to setting new policies and requirements. Over the years some of the proposed requirements were made in an unilateral manner (at least it was perceived that way by many). This highlights the desperate need for the histocompatibility committee and its leadership to improve their engagement with lab professionals, accrediting agencies, regulatory bodies, transplant community, and any pertinent stakeholders for any future policy proposals in order to gain buy-ins and support.

Region 11 | 09/12/2023

Sentiment: 5 strongly support, 3 support, 4 neutral/abstain, 0 oppose, 2 strongly oppose

A member agreed with removing this and said it is an unnecessary barrier to transplant. 

Michael Gautreaux | 09/12/2023

This requirement has been a waste of time since it was implemented. I guess it was felt that if a lab director or surgeon was "gaming" the system, then their signature would cause a last minute pang of conscience. This requirement only increased a patient's time to listing, especially if the laboratory director or surgeon was not available.

American Nephrology Nurses Association (ANNA) | 09/11/2023

ANNA highly supports this proposal to save time obtaining signatures which are currently required.

Robert Bray | 09/07/2023

I strongly support this proposal. While initially believed to provide an assurance that appropriate unacceptable antigens had been entered, it is not clear that this process has accomplished that goal. Combined with the probability of restricting access for a highly sensitized patient, the discontinuation of this process seems appropriate.

Anonymous | 09/05/2023

I strongly support elimination of the cPRA 99-100% form. I suspect that very few surgeons really look at the data provided by the lab before signing it anyway. Having both the electronic and paper forms is redundant and creates a lot of extra work with signing, scanning and emailing. Elimination of the form would speed up the time it takes for waiting patients to get the points they deserve.

Region 2 | 09/01/2023

Sentiment: 11 strongly support, 6 support, 2 neutral/abstain, 1 oppose, 0 strongly oppose

This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. Members expressed support, adding that this change should have happened long ago. Additionally, it will help avoid delays with activating candidates.

Region 4 | 08/30/2023

Sentiment: 8 strongly support, 7 support, 4 neutral/abstain, 2 oppose, 0 strongly oppose

This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. Two attendees commented that while the form was well intended, it delays the ability to get priority points and does not aid in the accuracy of the process.

OPTN Transplant Coordinators Committee | 08/28/2023

The OPTN Transplant Coordinators Committee thanks the OPTN Histocompatibility Committee for their work and for the opportunity to comment on this proposal.

A member expressed support for this proposal and believes it will remove an unnecessary extra step. Another member said they agreed, and that this paperwork may delay a candidate’s opportunity for transplant, especially smaller centers with less resources and staff to complete the form in a timely manner.

Harish Mahanty | 08/28/2023

I would agree that removal of the current policy that requires the extra step of requiring signatures to approve the candidate's unacceptable antigens in order for CPRA 99-100% candidates to gain allocation priority is acceptable as it is a redundant process.

Anonymous | 08/25/2023

As a person who analyzes HLA antibody data, assigns unacceptable antigens, enters the data into UNET, prepares the cPRA >98 form, emails the form and scanned raw data to lab director to review and requests the HLA director's signature, then emails the signed form to transplant center to collect surgeon and or physician's signature, I know it usually takes at least 2-5 days to complete that process. Even though it is not a weeks or months delay for a highly sensitized patient to be eligible to access the limited valuable organ offer, the requirement of that form does not serve its purpose as it was designed initially to benefit the patient. It creates unnecessary extra work for both the HLA lab and transplant center, result in allocation inefficiency of matched organ to the patient.

Jennifer Schiller | 08/24/2023

I agree with the proposed changes and the removal of this form. Despite its good intentions, it is a disadvantage to highly sensitized patients who are listed without the form in place, and an administrative burden overall.

Bobbie Rhodes-Clark | 08/24/2023

I fully support to remove the CPRA 99-100% form for highly sensitized kidney candidates. The intent of this form and the utility in clinical practice does not align. There are already standards in place that HLA data entered into UNOS is reviewed and verified.

Anonymous | 08/07/2023

While it is important to verify a high PRA for appropriate allocation points, I do feel that the process of having these forms "signed" prior to receiving points actually harms the patients that the policy was set up to benefit. If the required information could be added thru an electronic signature workflow, that might be a quick fix.

Peter Lalli | 08/03/2023

While these forms were initially well-intended, it does not appear that they have served the function for which they were devised. There has been no evidence to date that any center has inappropriately used CPRA to provide an advantage to their patients. Quite the opposite has occurred. These forms serve as a significant administrative barrier to highly sensitized patients to the point that many patients are being denied access to transplant while waiting for those forms to be signed by the appropriate parties. These highly sensitized patients are potentially missing out on lifesaving transplants simply because someone forgot to sign a form. There should be no reason at all that a patient should not receive their due access as soon as they are listed. As the data in the proposal shows, many patients have been denied access while they wait for these forms to be filled out. This is clearly and unfairly denying patients transplants, potentially adding to waitlist mortality simply because of an administrative barrier that really does not serve the intended purpose. This requirement should be removed immediately to allow any patient with a CPRA of >98% to receive their due points and begin getting regional and national priority to organs.

Caroline Alquist | 08/01/2023

I support the removal of this form. It was a well-intended safeguard that has not proven to be useful.

Anonymous | 07/27/2023

I don't believe the form adds any benefit.
Removing this requirement would benefit our patients ability to receive additional points and would reduce the burden on the transplant staff as well. Thank you!

David Maurer | 07/27/2023

This requirement doesn't really serve a useful purpose in my opinion. Because candidates do not receive priority until both HLA Director and Transplant Surgeon or Transplant Nephrologist enter attestation into UNOS Waitlist modules, it remains possible that some candidates who are qualified for priority due to HLA sensitization may miss out on offers while this form is pending completion. It could be that their only compatible offer occurs during the lag period while the form remains incomplete.