Steps towards reimbursing kidney donors--update from Frank McCormick

 I've written before about NLDAC, the federally funded National Living Donor Assistance Center, which operates under many regulatory constraints. (I'm on their advisory board.)

Frank McCormick brings us up to date on recent steps to relax some of those constraints.  Below I quote from his recent email:

"Since 2007, the federal government has had a program to reimburse low income organ donors for their travel and lodging expenses.  This program is currently administered by National Living Donor Assistance Center (NLDAC) at the University of Arizona.   The Secretary of Health and Human services (HHS) has the legal authority to administratively expand the mandate of this program.  Toward that end, the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB) has just scheduled a new rule change:

Title: Removing Financial Disincentives to Living Organ Donation 

Abstract: This proposed rule would amend the Organ Procurement and Transplantation Network (OPTN) final rule to further remove financial barriers to living organ donation by expanding allowable costs that can be reimbursed.  The changes would apply to specified incidental nonmedical expenses incurred toward living organ donation. 


2. The second front is centered on the Advisory Committee on Organ Transplant (ACOT), a non-government committee that advises the Secretary of HHS on organ transplant matters.  At its meeting on May 20, the committee heard a very informative presentation by Robert Merion of NLDAC: 

A key part of the presentation was NLDAC’s Vision for Expansion:
1. Expand eligibility for reimbursement to donors with incomes up to 500% of the federal poverty guidelines (it is currently 300%)
2. Waive income verification for donors needing less than $500
3. Approve applications from non-directed donors (i.e., living donors who do not have a specific intended recipient)
4. Reimburse wages lost due to organ donation
5. Reimburse child care/elder care expenses due to organ donation
6. Require NLDAC information to be given to all recipients and donors

ACOT endorsed the first five recommendations and forwarded them to the Secretary of HHS. "

Compensate living donors for lost wages and other expenses?

It seems like an idea whose time should come, and for which there's growing support:

One simple change the government could make to encourage kidney donation
Donors often forgo wages for a couple weeks to save a life. That can be fixed.
By Dylan Matthews

"there’s a group that helps people with the travel costs associated with donating. It’s called the National Living Donor Assistance Center (NLDAC), and it’s funded by the federal Department of Health and Human Services (HHS), which administers Medicare. But the group helps a relatively small number of donors.
...
"NLDAC can pay for “travel, lodging, meals, and incidental expenses,” but barring regulation from the HHS, it can’t reimburse lost wages or pay for child care for donors. The group is currently running a randomized controlled trial, funded by the Laura and John Arnold Foundation, in a handful of transplant centers where it does reimburse for lost wages to see if offering that increases living donations.

"But NLDAC could adopt that policy nationally, right now, with a simple regulatory change. No action from Congress would be required, according to NLDAC’s own analysis. The HHS can, on its own, issue a rule permitting NLDAC to reimburse lost wages and child care expenses. And randomized trial aside, we already have strong reason to think that reimbursing lost wages would significantly increase donations.
...

"Waitlist Zero has been pushing this change, and Rep. Matt Cartwright (D-PA), a leader in Congress on kidney issues, is on board. Curiously, the National Kidney Foundation, perhaps the most high-profile nonprofit working on kidney issues, has declined to back this modest change. Troy Zimmerman, the group’s vice president of government relations, told me on the record that the group “supports the concept of paid leave for living donors but has not taken a position on this specific proposal.”

Their reluctance to vocally support this move is puzzling and frustrating. Letting NLDAC cover lost wages is a very modest change that would clearly help people, and move us closer to a world where there are finally enough donors to end the waitlist of people whose lives depend on a kidney transplant."

**********

Here are some earlier posts about NLDAC (I've been on their advisory board since 2016):

Saturday, July 21, 2018  Effects of removing some financial dis-incentives to kidney donation through the National Living Donor Assistance Center (NLDAC)

Tuesday, October 3, 2017  The effect of paying the travel expenses of living kidney donors: Schnier et al. on NLDAC

Thursday, December 22, 2016 NLDAC announces a trial of Lost Wages Reimbursement for Living Organ Donors (funded by the Arnold Foundation)

Tuesday, September 27, 2016 National Living Organ Donor Assistance Center (NLDAC)

Effects of removing some financial dis-incentives to kidney donation through the National Living Donor Assistance Center (NLDAC)

Here's a recent paper looking at NLDAC. (I'm on their advisory board.)
It might help make the case for yesterday's proposed legislation...

Clinical Transplantation

 Volume 32, Issue 7

ORIGINAL ARTICLE

Full Access

Return on investment for financial assistance for living kidney donors in the United States

Amit K. Mathur 

Jiawei Xing 

David M. Dickinson 

Patricia H. Warren 

Kimberly A. Gifford 

Barry A. Hong 

Akinlolu Ojo 

Robert M. Merion

First published: 08 May 2018

https://doi.org/10.1111/ctr.13277

Abstract

Background

The National Living Donor Assistance Center (NLDAC) enables living donor kidney transplants through financial assistance of living donors, but its return on investment (ROI) through savings on dialysis costs remains unknown.

Methods

We retrospectively reviewed 2012‐2015 data from NLDAC, the United States Renal Data System, and the Scientific Registry of Transplant Recipients to construct 1‐, 3‐, and 5‐year ROI models based on NLDAC applications and national dialysis and transplant cost data. ROI was defined as state‐specific federal dialysis cost minus (NLDAC program costs plus state‐specific transplant cost), adjusted for median waiting time (WT).

Results

A total of 2425 NLDAC applications were approved, and NLDAC costs were USD $6.76 million. Median donor age was 41 years, 66.1% were female, and median income was $33 759; 43.6% were evaluated at centers with WT >72 months. Median dialysis cost/patient‐year was $81 485 (IQR $74 489‐$89 802). Median kidney transplant cost/patient‐year was $30 101 (IQR $26 832‐$33 916). Overall, ROI varied from 5.1‐fold (1‐year) to 28.2‐fold (5‐year), resulting in $256 million in savings. Higher ROI was significantly associated with high WT, larger dialysis and transplant costs differences, and more NLDAC applicants completing the donation process.

Conclusions

Financial support for donor out‐of‐pocket expenses produces dramatic federal savings through incremental living donor kidney transplants.

The effect of paying the travel expenses of living kidney donors: Schnier et al. on NLDAC

The National Living Donor Assistance Center (NLDAC) can only give a very little money to economically deprived kidney donors who are donating to economically deprived recipients. But that has an effect. Here's a recent paper:

SUBSIDIZING ALTRUISM IN LIVING ORGAN DONATION
Kurt E. Schnier, Robert M. Merion, Nicole Turgeon and David Howard, Economic Inquiry
Version of Record online: 30 AUG 2017
DOI: 10.1111/ecin.12488

Abstract
The current supply of deceased donor organs is insufficient to meet the growing demand for transplantable organs. Consequently, candidates for kidney transplantation are encouraged to find a living donor. In 2008, the Department of Health and Human Services began to reimburse donors' travel-related expenses via the National Living Donor Assistance Center (NLDAC). Using variation in transplant centers' applications for donor assistance, we use a difference-in-difference model to estimate the relationship between the NLDAC and living donor kidney transplants. We find that among participating transplant centers, the program increased the number of living donor kidney transplants by approximately 14%.

Global kidney exchange and repugnance in the AJT: comments and replies

The forthcoming issue of the American Journal of Transplantation is going to have a number of conflicting views about Global Kidney Exchange (GKE).  Just as yesterday's post showed how Kidney Exchange faced some repugnance at the turn of this century, these interactions show that GKE will have to overcome some repugnance too. (I just returned from Geneva where I talked about GKE among other things, in an attempt to start bridging this divide.)


It all started with our article proposing GKE and reporting the case of a Philippine patient-donor pair, which came out in March, along with an accompanying editorial suggesting that maybe the whole idea is repugnant.

Here's the original article:

Kidney Exchange to Overcome Financial Barriers to Kidney Transplantation
by M. A. Rees, T. B. Dunn, C. S. Kuhr, C. L. Marsh, J. Rogers, S. E. Rees, A. Cicero, L. J. Reece, A. E. Roth, O. Ekwenna, D. E. Fumo, K. D. Krawiec, J. E. Kopke, S. Jain, M. Tan, S. R. Paloyo
American Journal of Transplantation, Volume 17, Issue 3 March 2017, Pages 782–790

And here's the accompanying editorial:
Walking a Tightrope or Blazing a Trail?
by A. C. Wiseman, J. S. Gill

Here is our forthcoming reply to the editorial

Global kidney exchange: Financially incompatible pairs are not transplantable compatible pairs

M. A. Rees, S. R. Paloyo, A. E. Roth, K. D. Krawiec, O. Ekwenna, C. L. Marsh, A. J. Wenig and T. B. Dunn

Version of Record online: 1 SEP 2017 | DOI: 10.1111/

And here is a letter saying that GKE is essentially organ trafficking…

Opposition to Irresponsible Global Kidney Exchange

Francis L. Delmonico and Nancy L. Ascher

Accepted manuscript online: 21 AUG 2017 09:05AM EST | DOI: 10.1111/ajt.14473

·        Abstract  Article  PDF(63K)

And our replies:

You have free access to this content

People should not be banned from transplantation only because of their country of origin

Alvin E. Roth, Kimberly D. Krawiec, Siegfredo Paloyo, Obi Ekwenna, Christopher L. Marsh, Alexandra J. Wenig, Ty B. Dunn and Michael A. Rees

Accepted manuscript online: 1 SEP 2017 09:25AM EST | DOI: 10.1111/ajt.14485

• Abstract
• Article
• PDF(65K)

1. 
   
2. You have free access to this content

   Open dialogue between professionals with different opinions builds the best policy
   

   Ignazio R. Marino, Alvin E. Roth, Michael A. Rees and Cataldo Doria

   Version of Record online: 11 SEP 2017 | DOI: 10.1111/ajt.14484

   • Abstract
   • Article
   • PDF(119K
    have free access to this content
3. Here's the text of the Roth et al. letter:

"Previously [1,2], we described how a Filipino husband-and-wife patient–donor pair were included in an American kidney exchange.1,2 Delmonico and Ascher object in the strongest terms.3 They write that ethical Global Kidney Exchange (GKE) with patient–donor pairs from the developing world “is not feasible when the culture is so experienced with organ sales.”

Among the proposers of GKE are experienced surgeons and clinicians, a senior lawyer, and a veteran market designer. We take black markets with the utmost seriousness. That’s why the first GKE pair was started with a husband and wife. We think the right course of action is to proceed carefully, slowly at first, and with constant monitoring. The second GKE pair from Mexico were cousins cared for by Dr. Ricardo Correa-Rotter, a world-renowned nephrologist and signatory of the Declaration of Istanbul.4,5

We also take seriously long-term postoperative care for both patients and donors. That’s why we propose GKE in partnership with developing countries that already have some first-rate hospitals that perform living donor transplantation. Rees et al. describe how we coordinated care with the Philippine General Hospital and St. Luke’s Medical Center in Manila.2 We also provided an escrow fund for long-term continuing care. Ivan Carrillo describes our care of the donor and recipient in the second GKE and it is clearly celebrated by Mexican media as a beautiful way to help citizens of both Mexico and the United States.4,5

Kidney exchange (KE) itself is a relatively new “matching market,” of a kind that does not involve any payments to donors. It has been successfully launched in many countries, and proposals for international cooperation are underway.6 What makes KE special is that two or more patient–donor pairs help each other. What makes GKE special is that helping first-world patients get transplants saves money, because dialysis is so expensive, and these savings can benefit poor patients and donors in poor countries who would otherwise be unable to help themselves, but can participate in GKE for free.

Delmonico and Ascher propose that poor people with ESRD in poor countries, and the donors who love them, must all be regarded as potential criminals who would inevitably corrupt first-world medicine by being included in it. In the current political climate this is a bit like proposing a blanket ban on granting asylum to refugees from some countries. We do not adopt this point of view. On the contrary, GKE is a proposal that says there are many deserving patients who need our help, who we can help, and who can help us—if we invite them carefully and take care of them attentively.

Fear is not the path forward. Bold, careful innovation has led transplantation to where it is today, and remains our best collective future.

Disclosure The authors of this manuscript have no conflicts of interest to disclose as described by the American Journal of Transplantation.

References
1. Rees MA, Paloyo S, Roth AE, et al. Global Kidney Exchange: Financially Incompatible Pairs Are Not Transplantable Compatible Pairs. Am J Transplant. 2017;17:782-90.
2. Rees MA, Dunn TB, Kuhr CS, et al. Kidney Exchange to Overcome Financial Barriers to Kidney Transplantation. Am J Transplant 2017;17:782-90.
3. Delmonico FL, Ascher NL. Opposition to Irresponsible Global Kidney Exchange. Am J Transplant 2017;17:IN PRESS THIS ISSUE.
4. A bridge of life: Global kidney exchange between Mexico and the U.S. (Accessed 8/23/2017, at http://marketdesigner.blogspot.com/2017/04/a-bridge-of-life-global-kidney-exchange.html.)
5. Carrillo I. Un puente de vida (English Translation: A bridge of life). Newsweek en Español 2017 April 14, 2017:16-25.
6. Biró P, Burnapp L, Haase B, et al. Kidney Exchange Practices in Europe, First Handbook of the COST Action CA15210: European Network for Collaboration on Kidney Exchange Programmes (ENCKEP)2017.
**********

Today I'm in D.C. at a meeting of NLDAC, the National Living Donor Assistance Center.

NLDAC announces a trial of Lost Wages Reimbursement for Living Organ Donors (funded by the Arnold Foundation)

Here's some good news in an email that arrived yesterday from NLDAC, the National Living Donor Assistance Center (about which I have had several recent and not so recent posts).  Up until now, NLDAC has only been able to provide travel assistance to some means-tested kidney donors. The new trial will allow the effect on donation of also reimbursing lost wages.

Lost Wages Reimbursement for Living Organ Donors Trial Announced

FOR IMMEDIATE RELEASE Media Contact: Diane Mossholder 703-414-7870 diane.mossholder@asts.org   Arlington, VA – December 21, 2016: The National Living Donor Assistance Center (NLDAC) announces that it will conduct a randomized controlled trial that will assess the impact of interventions intended to remove financial barriers to living organ donation through wage reimbursement.  NLDAC was established in 2007 to administer a grant funded by the U.S. Health Resources and Services Administration to provide greater access to transplantation for persons who want to donate, but cannot afford the travel and subsistence expenses associated with donation. It currently provides travel and subsistence funds for nearly 1000 people per year who wish to become living organ donors to offset their expenses related to donation. Living donors usually travel at least three times to the transplant center and are required to stay near the hospital for up to two weeks after the transplant surgery for monitoring. They are unable to work during their donation and recovery time, and the loss of wages can be a significant financial barrier. This study will provide data to help answer the question of whether removing that barrier increases living donation in the United States. The Laura and John Arnold Foundation provided funding for the trial, which will be administered by the American Society of Transplant Surgeons in partnership with the Arbor Research Collaborative for Health, with additional researchers from University of Arizona, the Wharton School of the University of Pennsylvania, and Mayo Clinic Arizona.  Five transplant centers with active living donor transplant programs will participate in the trial. “Removing financial disincentives to organ donation has long been a goal of ASTS,” said Timothy L. Pruett, MD, president of the American Society of Transplant Surgeons (ASTS). “I’m pleased that we are able to conduct this trial and gather data on the extent to which the prospect of lost wages discourages donors from coming forward or even being asked to consider donating. With more than 120,000 people waiting for an organ in the United States, we must do everything possible to ensure that those willing to donate are able to do so without financial harm to themselves or their families.” “Our study design – potential transplant recipients will be randomly offered or not offered wage reimbursement for their donors – incorporates a high level of scientific rigor,” noted Robert M. Merion, MD, president and CEO of Arbor Research Collaborative for Health. “When the study is completed, we will know much more about the role played by lost wages as a barrier to living organ donation, and the extent to which removal of that barrier leads to more living donor transplants and improved lives for patients. We are delighted that the Laura and John Arnold Foundation has recognized the societal importance of this question.” The trial will begin in 2017 and is projected to run through 2018. ### About NLDAC The National Living Donor Assistance Center (NLDAC) was established in 2007 to provide greater access to transplantation for persons who want to donate, but cannot otherwise afford the travel and subsistence expenses associated with donation. The program is funded by grant number U13HS07689 from the Healthcare System Bureau, Health Resources and Services Administration, U.S. Department of Health and Human Services. It is administered by the American Society of Transplant Surgeons, University of Arizona Health Sciences, Arbor Research Collaborative for Health, Washington University – Missouri, and Mayo Clinic – Arizona. For more information, visit LivingDonorAssistance.org.   About ASTS Established in 1974, the American Society of Transplant Surgeons (ASTS) is the oldest abdominal organ transplant society, serving approximately 1,800 surgeons, physicians, scientists, pharmacists, coordinators, and advanced transplant providers. ASTS is committed to fostering the practice and science of transplantation and guiding those who make policy decisions by advocating for comprehensive and innovative solutions to the needs of our members and their patients. ASTS is a nonprofit organization in Arlington, Virginia. For more information, visit ASTS.org. About Arbor Research Arbor Research Collaborative for Health is committed to improving patient care through research that shapes medical policies and practice. In particular, Arbor Research conducts health outcomes research on chronic disease and end-stage organ failure, with expertise in biostatistical analysis, clinical practice, health economics, public policy, database management and integration, and project coordination. Through research projects that are national and global in scope, Arbor Research’s scientific collaborations provide valuable and timely information to the worldwide health care community. A full description of the project portfolio is available at ArborResearch.org.   About the Laura and John Arnold Foundation LJAF is a private foundation that is working to improve the lives of individuals by strengthening our social, governmental, and economic systems. It has offices in Houston, New York City, and Washington, D.C. www.arnoldfoundation.org.

National Living Donor Assistance Center (NLDAC) Links

If someone you know in the U.S. needs travel assistance to be a living kidney donor, let them know about NLDAC:

National Living Donor  Assistance Center

Each year, the NLDAC Advisory Group meets to review program information and make recommendations for improvements. This year, the Advisory Group meeting was led by their new chair, Zoe Stewart, MD, PhD, MPH. We would like to thank this dedicated group of volunteers for their time and expertise: Brenda Dyson; Cathy Garvey, RN, BA, CCTC; Adam Gray, LCSW, CCTSW;  Maryl Johnson, MD; Marie Morgievich, BS, BSN, MSN, CCTC; Lisa Morrison, Kay Payne, PhD; Al Roth, PhD; Jennifer Steel, PhD; Jane Tan, MD, PhD, MS; Betsy Walsh, JD, MPH; Errol Williams; Alexander Wiseman, MD; Warren (Kip) Wright, MSW, LCSW; Mesmin Germain, MPH, MBA (Ex Officio); and Frank Holloman (Ex Officio).  NLDAC Advisory Group and Program Team Members  September 30th, 2016 Arlington, VA NLDAC Survey Comments - September 2016 "I am so appreciative that this program exists to help the process run smoothly!! Thank you SO very much!"-Living Donor, Methodist Specialty & Transplant Hospital, San Antonio, TX "Over all this was wonderful experience and I would do it again if was able."-Living Donor, Walter Reed Army Medical Center, Bethesda, MD "Very helpful - would have been very difficult financially without the help."-Living Donor, Rochester Methodist Hospital - Mayo Clinic, Rochester, MN "You guys were amazing. I could not have donated without your help!" -Living Donor, University of Utah Medical Center, Salt Lake City, UT "You all do a great job. I cannot see anything to improve the NLDAC. Thank you so much for helping me and my family. Thanks!!!" -Living Donor, University of Maryland Medical System, Baltimore, MD "This is a wonderful program that made a huge difference in my life. It made it possible not to worry about the fact that I was not supporting the rest of my family because I was spending so much on the process. HUGE BLESSING!"-Living Donor, Abbott Northwestern Hospital, Minneapolis, MN Contact Us! If you have questions or comments about our program or need assistance completing an application, please contact the NLDAC team at Toll Free: 1-888-870-5002, Phone: 703-414-1600, Fax: 703-414-7874 or E-mail: nldac@livingdonorassistance.org. We are located in Arlington, VA and are available M-F 9:00am-5:00pm ET. NLDAC provides services via a HRSA grant awarded to the University of Arizona and the partners listed below.  Health Resources and Services Administration | American Society of Transplant Surgeons | University of Arizona Health Sciences | Arbor Research Collaborative for Health | Washington University - Missouri | Mayo Clinic - Arizona Funding for this project is supported by grant number U13HS07689 from the Healthcare System Bureau, Health Resources and Services Administration, U.S. Department of Health and Human Services.  The contents of this electronic newsletter are solely the responsibility of the authors and do not necessarily represent the official views of the funder.   Educational Videos #1 Who is Eligible for NLDAC? #2 How to Apply for NLDAC #3 After NLDAC Application is Approved NLDAC Brochure and Poster Order Form Transplant Center Application Activity Report Order Form Worksheets English NLDAC Eligibility Screening Tool Donor Application Worksheet Recipient Application Worksheet Financial Hardship Waiver Worksheet Worksheets Spanish Donor Application Worksheet Recipient Application Worksheet Financial Hardship Waiver Worksheet