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Removing Financial Disincentives to Living Organ Donation 

A Guide to Making a Comment

The federal government is complicated. Hearing about draft regulations and comment periods and rulemaking processes can make anyone’s eyes glaze over, but the upshot is simple. You have the chance, until February 18th, to submit a comment online, and the government is legally required to listen to your comment when making its policy on living organ donation. This document is a guide for how best to use that opportunity to make your voice heard on donor support policy.

Background

An existing program reimburses travel expenses for a few living donors. In July, President Trump ordered that program expanded to cover most expenses (like lost wages) for many more donors donors. Studies find the average donor spends $4,200, so this is a huge change. Federal bureaucrats have published an imperfect draft of the rule implementing Trump’s Executive Order. Now the public gets to comment on that draft, and then the agency will revise the rule.

Helpful Comment Messages

The pages below offer extensive background and possible revisions as an optional resource for making your comment. But you do not need to be an expert or read every last word in order to express your views. A quick comment you post now is better than a lengthy one that never gets finished. Here are some themes that you may want to include in your comment.

  1. Support for Reimbursing Donors: This may sound obvious, but you should express your opinion about the policy and why it matters.
  2. Personal Experiences with Financial Barriers to Donation: Have you or anyone you know experienced financial disincentives to donating? If so, discuss that experience.
  3. The Urgency of Change: This policy was published more than two months late and puts off key parts of Trump’s order for later. Expressing the need for donors to be reimbursed ASAP is important to avoiding future delays.
  4. Expanding Who Can Be Reimbursed: Right now, only 8% of donors receive reimbursement in the program, which only applies to donors whose recipients earn less than 300% of the poverty line. Non-directed donors are not eligible. Trump ordered this changed, but that change wasn’t included by the agency. Reimbursing as many donors as possible is important. Waitlist Zero recommends the 300% number should be changed to 600%.
  5. Reimbursement Should Be as Broad as Possible: Forcing donors to pay money to give their organ is a travesty. The more disincentives we remove to donation, the more people will donate, saving lives and money. Program benefits should be defined liberally to remove as many barriers as possible.
  6. Support for Waitlist Zero’s Comment: Waitlist Zero is submitting a very detailed comment (available here). If you would like to endorse it, that would increase its impact.

Comment Now

To submit a comment, go to this link: https://www.federalregister.gov/documents/2019/12/20/2019-27532/removing-financial-disincentives-to-living-organ-donation#open-comment

Please share this with friends and colleagues ask them to comment too.

 

 

 

Table of Contents

Background
  1. Overview
  2. Existing Programs Background and History
  3. What Types of Expenses Do Donors Incur?
  4. Will Reimbursing Donors Increase Donation?
  5. What Will This Cost?
Possible Comment Areas
  1. Urgency of Change: This needs to be implemented as soon as possible
  2. Cost-Benefit Analysis: Reimbursing more donors means more transplants and fewer costs.
  3. Lost Income, Not Just Lost Wages: Donors should be reimbursed for limited sick days, foregone contract labor, and other expenses.
  4. Remove “Primary Caregiver” as a Qualification to Receive Childcare and Eldercare Reimbursement
  5. Donor Caretakers Should Have Their Expenses Reimbursed Too
  6. Removing Disincentives Beyond Reimbursement
  7. The Phrase “Payer of Last Resort” Should Be Removed from the Regulation
  8. Who is Eligible to Participate?
Additional Resources

 

Background

Overview

Established by a law in 2004, the National Living Donor Assistance Center is a program that receives federal funds to reimburse the travel expenses for living organ donors whose recipients earn less than 300% of the poverty line. It currently reaches about 8% of donors each year, and 75% of its donors say they would not have donated without the program.[1] On July 10, 2019, President Trump ordered that a proposed rule be published by October 10th to expand this program to also reimburse lost wages, childcare, and eldercare and to increase the income cap for which donors are eligible.[2]

On December 20th, the Department of Health and Human Services (HHS)  published a draft regulation implementing this order. The entire text of the regulation, including its background and rationale, runs 28 pages,[3] but its substantive changes to the rules governing the program were very brief. It simply adds the following language:

“(a) The following incidental non-medical expenses incurred by donating individuals toward making living donations of their organs may be reimbursed: (1) Lost wages; (2) Child-care expenses; and (3) Elder-care expenses.”

The changes to donor eligibility were explicitly left to a future rulemaking. Additionally, the draft requested comments on “’foregone medical insurance benefits,’ defined as the loss of a wage supplement for medical insurance premiums provided by an employer” and “any literature or evidence on additional financial barriers to organ donation.” Significant issues were left open, including how to assess lost wages, what limit to put on childcare costs, and how to triage benefits for donors if the funds appropriated prove scarce. These may be a part of future rulemaking and protract the timeline further.

The public has until February 18th  to comment one this rule, which can be done here. Over the following several months, the responsible federal agency (the Health Resources and Services Administration – “HRSA”) will then read the comments, group them into common concerns, revise the rule in response, respond to the concerns that did not lead to changes, and publish a final rule, which should be made public in early summer.

Existing Program Background and History

Currently, the National Living Donor Assistance Center is administered by a cooperative agreement between HRSA and the American Society of Transplant Surgeons. The program was authorized by the Organ Donation Recovery and Improvement Act of 2004, which amended 42 U.S.C. 274f to authorize grants “for the reimbursement of travel and subsistence expenses incurred by [living organ donors].” A competitive bidding process was concluded on September 14, 2006 and a four-year contract was awarded to a team including the primary investigator from the University of Michigan (now at the University of Arizona) and the American Society of Transplant Surgeons, which has run the program ever since.[4] The current Cooperative Agreement was awarded in September, 2019 and extends to the end of August 2024. Prior to this December, the most recent regulations concerning income guidelines and eligibility for donors to participate in NLDAC were published in 74 FR 29218 on June 19, 2009.

In June 2019, NLDAC also received a contract with HRSA for a pilot study of reimbursing lost wages. Thirty-four bipartisan members of Congress wrote a letter endorsing the program’s expansion, and the House budget included $10M in funding for the program. The OIRA Spring Agenda scheduled rulemaking to expand the program to begin by September, 2019. President Trump ordered HHS to initiate a Notice of Proposed Rulemaking by October 10th, 2019 expanding the program to raise its income cap and reimburse lost wages, childcare, and eldercare expenses. NLDAC was awarded another five-year contract to run the travel reimbursement program beginning in September, 2019.

What Types of Expenses Do Donors Incur?

Several studies have investigated what expenses are experienced by living kidney donors. Their outcomes are roughly similar and imply a per-donor cost of approximately $4,000-4,900.

KDOC Study: The most authoritative of the three is the Kidney Donor Outcome Cohort (KDOC) study conducted by Dr. Rodrigue of Harvard Medical School, which estimated both pre- and post-donation costs for donors and their caretakers.[5]4  This observational study, published in two papers, enrolled live donors (194 for pre-donation costs; 182 for post) from six transplant centers and tracked their expenses before and after surgery. Because the study only included participants who completed donor surgery, it may understate pre-donation costs for donor candidates who are ruled ineligible or otherwise do not donate.

The KDOC study pre- and post-donation estimated a total average cost of about

$4,200 (including donors who incur no lost wages or other expenses). Costs varied widely among donors with many experiencing very little costs (due to donating a local center and/or having paid medical leave), and some incurring hefty expenses.

Reimbursable Expenses
Pre-Donation Average Expense
Direct Costs* $523
Donor Lost Wages $187
Companion Lost Wages $76
Lost Wages $1,660
Caregiver Lost Wages $377
Direct Costs* $1,157
Service Expenses $225
Donor Lost Wages $1,847
Other Donor Costs $1,905
Other Companion/Caretaker Costs $453
Total Costs $4,205

 

*Direct costs include transportation, lodging, meals, over-the-counter medicine, and other out-of- pocket expenses

** Service expenses include costs for childcare, eldercare, and other services the donor would normally perform for themselves when not recovering from surgery

Other Studies and Sources: An earlier paper by Klarenbach[6]5 studied 100 donors from seven Canadian centers between 2004 and 2008 and found a mean total cost to the donor of $3,268 (roughly $4,902 in today’s American dollars) with $2,144 of that in lost pay, and $1,780 in other expenses (including non- donor costs).

Additionally, when the National Living Donor Assistance Center surveyed their participating donors, they found that 39% of them reported lost wages, which averaged $2,784.[7] Because NLDAC only reimburses donors who earn under 300% of the poverty line, the average lost wages for all donors is likely higher, but the 39% figure is roughly in line with what other studies have found for the percentage of donors who incur lost wages, with Rodrigue’s study estimating 40% of total lost work hours were unpaid and Klarenbach finding 47% of donors experienced lost pay.

A final data point is that the nonprofit, Renewal, which provides transplant eduation and donor support services to the Orthodox Jewish community and facilitates roughly 80 transplants per year, estimates their total per-donor reimbursement between travel, childcare, lost wages, and other expenses to be approximately $7,500.

Will Reimbursing Donors Increase Donation?

Significant evidence exists that expanding reimbursement would increase donation:

  1. Similar Reimbursement Measures Have Increased Donation
    • After Israel began reimbursing donor lost wages and providing other benefits, living donation nearly quadrupled;[8]
    • A 2017 study of NLDAC travel reimbursement found a 14% increase in transplant at participating centers.[9]
    • A 2015 study of state tax deductions for donor reimbursement found a 52% increase in donation to non-family members;[10] and
    • In a survey of NLDAC donors, 75% said they would not have donated without reimbursement.[11]
  2. Donor Income Significantly Affects Transplant Rates
    • Donation varies directly by income level[12] – raising the average rate of donation to that of the top income quintile would increase donation by 35%; and
    • Donation rates for the lowest three income quintiles declined after the last recession;[13]
Location Intervention Effect on Donation
United States Travel reimbursement for income-eligible donors 14% increase in participating centers
Israel Generous paid medical leave, five years of free health insurance and other benefits 231% increase
New Zealand Lost wage reimbursement 23% increase
Saudi Arabia Package of benefits including expense reimbursement and health insurance 222% increase

 

Authors of a study of past donor support efforts[14] estimate that for every $1,000 in the benefits the average American donor receives, donation rates in the U.S. would increase by 300 transplants.

What Will This Cost?

Long-term, the reimbursement program should require $15M-$39M each year depending on the percentage of donors eligible (65-85%), percentage of eligible donors who participate (70-90%), cost per donor ($5,000-$6,000, including overhead), and total number of living donor kidney transplants (6,500-8,500).

A recent study found that the travel reimbursement program saved $28 to CMS for every $1 it spent.[15] Medicare estimates the cost-savings per live-donor transplant at $136K thousand, which would imply an annual net savings of $59M-$133M on increases of 550-1,250 transplants, depending significantly on the percentage of donors eligible and the percentage of eligible donors reached by the program.

Possible Comment Areas

Below are a list of approaches for how the draft regulations could be improved. When writing your comment, consider including some of these points, depending on which ones seem most valuable or important to you.

  1. Urgency of Change: This needs to be implemented as soon as possible

Background: The way this rule is written leaves many open items that may require another round of regulation, which would take at least another six months before donors can start being reimbursed . For example, the regulations do not address how lost wages  or childcare expenses are determined, any verification measures, the caps on how many dollars one donor can receive, which donors to prioritize if program funds are scarce, as well many other details about the program.

This rule was published late, which will unfortunately delay its implementation. In the federal government’s 2019 Spring Agenda, this regulation to remove donor disincentives was calendared for September 1st. The President’s Executive Order mandated that it be published no later than October 10th. The draft rule was not published until December 20th, several months behind schedule. The rule also did not include the revisions to donor eligibility ordered by the President. This is particularly frustrating because eligibility restrictions are so tight that the program historically has spent less than the money it was appropriated.

Recommendation: One potential point to emphasize in comments is disappointment with the delay and the need to treat this policy with urgency going forward. These are matters of life and death. According to the regulation itself, hundreds or thousands more transplants will result from this program’s being implemented. Delay means that some patients will die waiting who would otherwise receive a transplant. Moreover, it is unconscionable that some potential donors currently have to decide between going into debt or saving the life of someone they care about by giving their organ.

  1. Cost-Benefit Analysis: Reimbursing more donors means more transplants and fewer costs.

Background: When making regulations like this one, the government is required to “take into account benefits and costs, both quantitative and qualitative.” The proposed rule states the benefits of this rulemaking as an increase in living organ donation along with the corresponding cost reductions compared to the affected patients remaining on dialysis. (Medicare estimates savings per live donor transplant as $136,000).

Recommendation: Given the evidence showing that more expansive support for donors means greater increases in donation and greater cost savings, one potential comment would be to argue that this cost-benefit analysis requires the broadest possible definition of the relevant terms. For example:

  1. Lost income should be included instead of lost wages to include independent contractors like Uber drivers.
  2. Parents should not have to be the primary caregiver in order to receive reimbursement for childcare expenses.
  3. People caring for the donor (e.g. a spouse who takes time off the day of the surgery) should be eligible to receive reimbursement for their lost wages and other expenses.
  4. The program should not be a “payor of last resort” as described in the regulation.
  5. Broader disincentives like surgical complications could be ameliorated by compensating donors for their risks.

3. Lost Income, Not Just Lost Wages: Donors should be reimbursed for limited sick days, foregone contract labor, and other expenses.

The regulatory language adds “lost wages” as an allowable expense to reimburse, but there are other types of income besides wages that are important to potential donor candidates. For example, contract labor like driving an Uber may not be accountable as lost wages, but it is vital to people’s livelihoods. Therefore, the phrase “lost income” may be better than lost wages.

Additionally, it would be valuable to specify that donors should be reimbursed for using limited paid sick days, vacation pay, or disability payments on their donor surgery which they would otherwise be able to utilize for other purposes.

  1. Remove “Primary Caregiver” as a Qualification to Receive Childcare and Eldercare Reimbursement

Background: The regulatory draft as written limits reimbursement for childcare and eldercare only to primary caregivers.

Recommendation: This limitation could be removed as confusing and unnecessarily restrictive. If a parent works full-time and their spouse does not, does that mean they should be ineligible to have childcare expenses reimbursed during recovery? If two parents work full-time, which one is the primary caregiver? The policy also raises significant monitoring issues with how one could prove they are or are not a primary caregiver for the purpose of this requirement. Better to allow donors with caretaker responsibilities for children or elders to receive reimbursement if they need to pay someone else to take on those responsibilities during their recovery.

  1. Donor Caretakers Should Have Their Expenses Reimbursed Too

Background: According to the Kidney Donor Outcome Cohort study estimating donor expenses, about 20% of all costs incurred during donation are incurred by the donors’ caretakers. The travel reimbursement program that is being expanded currently reimburses caretaker travel expenses, but the new regulations exclude donor caretakers from receiving reimbursement for their expenses.

Recommendation: The financial burden donation imposes on a donor’s family and friends is equally a disincentive to donation and could therefore be removed. This could be accomplished simply by inserting the phrase “and their caregivers” after “donating individuals” in 121.14(a) of the draft regulation.

  1. Removing Disincentives Beyond Reimbursement

Background: The regulation as written only reimburses expenses incurred during the donation process. But there are significant other disincentives to donation beyond direct expenses. One paper estimates these disincentives as equivalent to $38,000 in value.[16] These disincentives include the surgical risks of donation, the long-term risks to donor health, the inconvenience and discomfort of surgery, and the concern that a friend or relative may need a kidney in the future. Additionally direct reimbursement of demonstrable expenses may not fully account for all the financial barriers created by donation. For example, someone who is unemployed or underemployed may perform informal labor for friends and family (such as childcare, cleaning, meal prep, or chores) in implicit exchange for room and board or other non-cash compensation.

Recommendation: The regulation should consider removal of disincentives beyond reimbursement of expenses. For example, the program could provide life insurance to donors for the risk of surgery. Or eligible donors could receive compensation for the discomfort of surgery.

One specific recommendation might be that donors who are not employed full-time receive 40 hours of minimum wage for the weeks for which they are incapacitated. This would be in consideration of any informal labor they typically perform but are now unable to provide.

  1. The Phrase “Payer of Last Resort” Should Be Removed from the Regulation

Background: The statute authorizing this program forbids reimbursement to a donor whose expenses are paid or could reasonably be expected to be paid by an insurer or the transplant recipient.[17] The new draft regulation background section goes further and repeatedly says “The Program was designed to be the payer of last resort.”

Recommendation: This phrase “payer of last resort” goes beyond what the statute says and should be removed from the draft regulation. It implies that the program’s reimbursement should be as limited as possible and also seems to indicate that transplant recipients should be required to reimburse their donors as a matter of course. This is an unreasonable expectation to impose on recipients, and it also infects the donor-recipient relationship with uncomfortable monetary overtones that are best avoided. It is certainly true that the program, as statutorily required, should not reimburse expenses that have already been reimbursed by the recipient. But describing it as a payer of last resort is overly narrow and completely ignores the benefits of reimbursing donors generously.

  1. Who is Eligible to Participate?

Background: This draft regulation does not include changes to which donors are eligible to participate in the program. Those changes are left for an unspecified future date. Currently, eligibility is determined not by the donor’s income but by the recipient’s income. Only donors with recipients who earn less than 300% of the poverty line are eligible for the program currently. This also means that non-directed donors are not eligible for reimbursement, because their recipients are unknown during the time where they would apply for reimbursement. This is particularly egregious both because of the generosity of non-directed donors.

Recommendation: Income eligibility should be determined by donor income, not recipient income, and it should be raised high enough that the vast majority of donors qualify. Waitlist Zero recommends changing the 300% figure to 600%, which would represent an income of about $72,000 for a single-person household. Non-directed donors should be deemed eligible for the program.

Additional Resources

[1] Warren P, Gifford K, Hong B et al. Development of the National Living Donor Assistance Center: reducing financial disincentives to living organ donation. Prog Transplant. 2014 Mar; 24(1): 76–81.

[2] Here’s the relevant language from the Order: “Within 90 days of the date of this order, the Secretary [of Health and Human Service] shall propose a regulation to remove financial barriers to living organ donation.  The regulation should expand the definition of allowable costs that can be reimbursed under the Reimbursement of Travel and Subsistence Expenses Incurred Toward Living Organ Donation program, raise the limit on the income of donors eligible for reimbursement under the program, allow reimbursement for lost-wage expenses, and provide for reimbursement of child-care and elder-care expenses.”

[3] Compared to 181 pages for the Center for Medicare and Medicaid Services regulation on deceased donation.

[4] For a more detailed discussion of the history of the program, see Warren P, Gifford K, Hong B et al. Development of the National Living Donor Assistance Center: reducing financial disincentives to living organ donation. Prog Transplant. 2014 Mar; 24(1): 76–81.

[5] Rodrigue, J.R. Schold JD, Morrissey P. et al. Predonation Direct and Indirect costs Incurred by Adults Who Donated a Kidney: Findings from the KDOC Study. Am J Transplant. 2015 Sep;15(9):2387-93. Rodrigue, J.R. Schold JD, Morrissey P. et al., Direct and Indirect Costs Following Living Kidney Donation: Findings From the KDOC Study. Am J. Transplant 2016 Feb: 16: 869–876

[6] Klarenbach S, Gill JS, Knoll G, et al. Economic Consequences Incurred by Living Kidney Donors: A Canadian Multi-Center Prospective Study. Am J Transplant. 2014 Apr; 14(4): 916–922.

[7] See Warren et al. 2014, supra.

[8] Donations increased from 65 in 2008 to 230 in 2018. See generally Lavee, J. Ashkenazi T., Stoler A et al. Preliminary marked increase in the national organ donation rate in Israel following implementation of a new organ transplantation law. Am J. Transplant 2013: Mar;13(3):780-5.

[9] Schnier K. Merion R. Turgeon N. et al. Subsidizing altruism in living kidney donation. Economic Inquiry 2018: Jan:56(1):398-423.

[10] Bilgel, F and Galle, B, Financial incentives for kidney donation: A comparative case study using synthetic controls. 43 J. Health Econ 103 (2015).

[11] Warren et al. 2014, supra.

[12] Gill J, Dong J., Rose C. et al. The Effect of Race and Income on Living Kidney Donation in the United States. J Am Soc Nephrol. 2013 Nov; 24(11): 1872–1879.

[13] Gill J, Dong J., and Gill J. Population income and longitudinal trends in living kidney donation in the United States. J Am Soc Nephrol. 2015 Jan;26(1):201-7

[14] Frank McCormick, Philip J. Held, Glenn M. Chertow, Thomas G. Peters and John P. Roberts. Removing Disincentives to Kidney Donation: A Quantitative Analysis. J. Am Soc. Nephrol. 2019 August:30(8): 1349-1357

[15]Mathur AK, Xing J, Dickinson DM, et al. Return on investment for financial assistance for living kidney donors in the United States. Clin Transplant. 2018; 32:e13277.

[16] McCormick et al., 2019, supra.

[17] The statute says “An award may be made under subsection (a) only if the applicant involved agrees that  the award will not be expended to pay the qualifying expenses of a donating individual to the extent that payment has been made, or can

reasonably be expected to be made, with respect to such expenses—

“(1) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program;

“(2) by an entity that provides health services on a prepaid basis; or

“(3) by the recipient of the organ.