(See here for the posted comment)
COMMENT
Removing Financial Disincentives to Living Organ Donation
Waitlist Zero and the living organ donors we represent applaud the federal government for its initial steps towards removing disincentives to donation. No one should need to pay money to give their organ, and the President’s Executive Order ordering the expansion of what donor expenses and which donors can be reimbursed is a welcome and long overdue policy change.
That said, the execution of the President’s order through the Health Resources and Services Administration’s (HRSA’s) rulemaking raises significant concerns about the agency’s commitment to this policy and to the welfare of donors. The Executive Order mandated a proposal within 90 days, but the Notice of Proposed Rulemaking (NPRM) was published only after 163 days had passed. The NPRM fails to include the ordered changes to donor eligibility, which are further delayed to an unspecified date. The legally operative changes to the program guidelines proposed by the NPRM seem to simply copy the language of the Order, rendering the delay even more puzzling. Key details of program implementation are left unspecified, such as how lost wages or childcare expenses are calculated, any verification measures for expenses, the caps on how many dollars one donor can receive, and which donors to prioritize if program funds are scarce. We are concerned that specifying these details will further delay the implementation of this morally urgent and life-saving policy.
In recent history, HRSA has at times seemed resistant to supporting donors and listening to donor voices. In 2015, HRSA rejected a request signed by over 1,000 living donors that it endorse the goal of promoting living organ donation. In recent years, as much as 40% of the funds appropriated by Congress to reimbursing donor expenses has been utilized for other HRSA purposes because constraints on donor eligibility under the program were so restrictive. At the May 2019 Advisory Committee on Transplantation (ACOT) meeting more than half the living organ donors who asked to make a comment were not given the opportunity to do so. (This was the first ACOT meeting in three years). A June 18 request by 14 transplant stakeholder groups for a meeting with HRSA to discuss living donation issues was rejected without a formal response or rationale.
We therefore feel that, when assessing the suggestions below and implementing the President’s order, it is imperative that HRSA respect donors’ sacrifice and treat this policy with the urgency that it deserves.
Cost-Benefit Analysis
Summary: Regulatory decisions are legally required to maximize net benefits. Given the extensive evidence that reimbursing donors will increase transplantation thereby reducing government expenditure, HRSA is legally
obligated to expand the categories of allowable reimbursement and eligible donors as broadly as possible consistent with the authorizing statute.
Executive Order 13879 directed the Secretary of Health and Human Services to “propose a regulation to remove financial barriers to living organ donation” that would “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.”
Executive Order 13563 directs agencies, when promulgating regulation, to “take into account benefits and costs, both quantitative and qualitative.” Executive Order 12866 says “In deciding whether and how to regulate, agencies should assess all costs and benefits of available regulatory alternatives, including the alternative of not regulating…. [I]n choosing among alternative regulatory approaches, agencies should select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity), unless a statute requires another regulatory approach.”
The proposed rule, “Removing Financial Disincentives to Living Organ Donation,” published to the Federal Register on December 20, 2019, states the benefits of this rulemaking as an increase in living organ donation combined with a corresponding reduction in federal Medicare outlays, which the NPRM estimates to create a net savings of $136,000 per live donor transplant.
The NPRM lays out significant evidence that providing benefits to donors increases donation, so we will not belabor that evidentiary support here. Suffice it to say that multiple countries (Israel, Saudi Arabia, New Zealand and the United States) have seen statistically significant increases after implementing donor support programs, and the size of the average benefit has varied directly with the size of the increase. There are additionally strong theoretical reasons to believe that reducing financial costs of a decision (or providing financial benefits for a decision) will cause more people to make that decision.
Therefore, the only way to meet the legal requirement of maximizing net benefit is to expand allowable donor benefits to the maximum extent allowed by statute. When assessing each proposed provision governing the reimbursement program, HRSA is obligated to choose the language which will provide the most benefits to donors. Given the policy goals and evidence laid out in the Notice of Proposed Rulemaking, not to do so would be an arbitrary and capricious decision.
Response to Potential Objections
Scarce Funding: It could be argued that, since HRSA does not control the amount of funding appropriated to the program, it should define the scope of possible benefits (and donors eligible to participate) in a conservative way so that the most needy cases receive full reimbursement. This would be a mistake. While it is true that a system for triaging benefits needs to exist to accommodate the possibility of scarce funding, that triage mechanism is distinct from the question of which benefits are allowed at all and which donors are eligible for the program. Expanding allowed benefits does not interfere with triaging which of those benefits receives priority for which donors where
resources are limited. On the other hand, if the scope of allowed benefits is restricted, that absolutely prevents additional donor reimbursement in cases of where funding is in fact sufficient (and additionally deters Congress from appropriating additional funds). Given that additional donor reimbursement is net-beneficial, foreclosing the possibility of that benefit would be irrationally harmful (and therefore arbitrary and capricious). In other words, expanding allowed benefits and eligible donors can only help the NPRM’s stated policy goals. It cannot hurt them.
To provide an example to make this point clear, let’s imagine that our suggestion below about changing “lost wages” in the regulation to “lost income” is adopted but the funds appropriated to the program are not increased. If contractor income or compensation for utilized vacation days were deemed more speculative or less urgent than lost wages, the rule governing the Preference Categories for use of limited funds could be revised to specify that, if the contractor estimates appropriated funds in a fiscal year will be scarce, lost wages should be reimbursed for all eligible donors (subject to other preference categories) before non-wage income would be allowed to be reimbursed for any donors.
Some current facets of the program are relevant to this discussion: first, the fact that the program historically has been too constrained to spend all the funds appropriated implies that significant skepticism is warranted for any argument in favor of restricting benefits because of the potential for insufficient funds. Second, a mechanism to triage reimbursement by donor and recipient income in a world of scarce funding already exists in the program’s guidelines (available at 74 FR 29218 par. 23- 26). This could easily be revised to accommodate any the relevant changes without foreclosing the possibility of net-beneficial reimbursements for donors.
Certainty of Costs vs. Uncertainty of Benefit: A second objection that could be made is that the costs borne by the government in reimbursing donors are definite but the benefits of increased transplants are speculative, so maximizing allowable donor benefits is not legally required by cost- benefit analysis.
The objection fails on multiple grounds. First, it proves too much and implies that the policy justification offered in the NPRM (which relies on the expected increase in transplant) is itself incorrect. Second, it ignores that the expected benefits exceed the fiscal costs of the program by at least one order of magnitude. A program that increased transplant rates by 20% (consistent with the experience of New Zealand, which saw a 23% increase in live donation from reimbursing lost wages alone) at a cost of $5,000 per donor (assuming all donors received reimbursement) would cost
$42,000,000 ((7,000 current donors + a 20% increase) * $5,000) and yield 1,400 additional transplants, which would save Medicare $190,400,000 per the NPRM’s estimate of $136,000 in cost savings per transplant for a net savings of $150,400,000. Assuming each transplant yielded 4.7 additional Quality Adjusted Life Years (QALYs) and each QALY is valued at $200,000, this would imply a net benefit of $1,464,400,000 over the cost of the policy.1 There is no reason to believe that reimbursement of lost income (or caretaker expenses or any of the other program expansion recommendations below) would have any less marginal impact than reimbursement of travel or lost wages, but even if evidence could be provided that would demonstrate those reimbursements’
1 See Held PJ, McCormick F, Ojo A et al. A Cost-Benefit Analysis of Government Compensation of Kidney Donors. Am J Transplant. 2016 Mar;16(3):877-85 for QALY gain and valuation estimates.
impact would be less (or that the overall impact of reimbursement would be less than the 20% estimate), that impact could still be 97% less powerful than what is anticipated based on past results before it ceased to be cost-beneficial and merely became cost-neutral. (See calculations in Table 1). Thus, there is no reasonable discount rate that could be applied due to lack of certainty that would render the broadest expansion of benefits to the broadest number of donors net-negative on a cost- benefit analysis.
Table 1
Estimated Policy Benefit
| QALYS Gained Per Transplant | 4.7 |
| Value per QALY | $200,000 |
| Medical Benefit Per Transplant (in dollars) |
$940,000 |
| Number of Additional Transplants Expected |
1,400 |
| Total Medical Benefit (in Dollars) |
$1,316,000,000 |
| Cost Savings Per Transplant | $136,000 |
| Gross Savings | $190,400,000 |
| Total Benefit (Savings + Medical Benefit) |
$1,506,400,000 |
| Expected Program Cost | $42,000,000 |
| Expected Net Benefit | $1,464,400,000 |
| Ratio of Cost to Benefit | 2.87% |
Living Donor Authority Over Program Implementation
Summary: Living organ donors have a uniquely valuable perspective into donor reimbursement and should be included in a formal structural way in the management and oversight of the program.
One revision we urge to the rules governing the donor reimbursement program is that living organ donors be formally given structural representation in overseeing and managing the program. Donors have a unique and valuable perspective on what financial barriers we face and how program implementation decisions affect donors in practice. There are a number of well-respected living organ donors in the transplant and medical professions (such as Janet Hiller and Macey Henderson of Johns Hopkins, Taira Foster of the University of Colorado Hospital, Diego Acero of Northwell Transplant Center, Doug Penrod of Northwestern, Dr. Nancy Ascher of UCSF, and Glenna Frey of the American Nephrology Nurses Association to name a few), so a rich talent pool for operational guidance and oversight exists. The donor and recipient populations have a structural role in the United Network for Organ
Sharing under the OPTN contract, so at minimum donors should be given similar authority in the donor reimbursement program and any contracting entities.
According to the cost-benefit analysis contained in the NPRM, providing additional donor benefits will yield additional transplants and reduce Medicare costs. (See Cost-Benefit Analysis above for a fuller discussion). Since donors are uniquely situated to identify the full range of costs and disincentives, empowering them in the reimbursement program’s oversight and administration will most rationally serve the goals of this policy.
Just as doctors and medical professionals have a unique perspective on reimbursing living organ donors and are currently included in administering the program, living organ donors have a similarly important and unique role and should receive equal authority to that of medical professionals.
Additionally, when evaluating the costs and benefits of regulations affecting living donor reimbursement, the qualitative benefit of reducing donor burden and honoring donor sacrifice should be included. While there is excellent evidence that reimbursing donors will increase donation and reduce cost, even if it did not, there would be strong normative reasons to leave donors as well off as possible post-donation (for the same reason that it is normatively valuable to provide wounded veterans healthcare whether or not it increases the number of Americans willing to serve in the military). This normative benefit should be taken into account when deciding the generosity of the regulation. In cases where there is no clear evidence that expanding donor benefits would be significantly harmful, the inherent normative value of supporting donors should create a default presumption in favor of expanding allowable benefits and the proportion of donors benefitted. It is normatively desirable to err on the side of generosity towards donors reciprocal to the generosity offered by the donors themselves.
Lost Income Instead of Lost Wages
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 many people’s livelihoods. 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.
Therefore, the phrase “lost income” would be better than lost wages, and the following language should be added after “lost income:” “including anticipated income from contract labor that would otherwise be performed but for donation, compensation for the use of limited paid sick days, vacation pay, or disability payments that donors would otherwise be able to use for other purposes.”
Additionally, donors who are not employed full-time should 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 for friends, family, or roommates, but are unable to provide during the duration of their recovery. For example, someone unemployed may perform cooking, cleaning, or childcare tasks at home as a way of earning room and board. Donating would interfere with their ability to perform those tasks, so they should receive imputed reimbursement for their time (including time they could otherwise apply for future employment).
Reimbursing Caretaker Expenses
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 (see Table 2 below for an estimated cost breakdown based on a series of observational studies conducted at six transplant centers).2 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. It is irrational to allow reimbursement for caretaker travel but not other caretaker expenses.
The financial burden donation imposes on a donor’s family and friends is equally a disincentive to donation and should 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.
It takes a village to give a kidney – imposing financial burdens on the donors friends and family tasked with caring for the donor will reduce donation and impair donor welfare. Therefore, removing these disincentives would increase donation and be normatively desirable.
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Table 2 Reimbursable Expenses
*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
2 See 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.
Remove “Primary Caregiver” for Childcare and Eldercare Expenses
The regulatory draft as written limits reimbursement for childcare and eldercare only to primary caregivers. 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. It would be 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.
Removing Disincentives Beyond Reimbursement
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.3 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.
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 or long-term health risks. Donors could receive money in a Flexible Spending Account to use on healthcare expenses through the program.
Therefore, we recommend §121.14(b) (which currently reads “reserved”) with the language “The following disincentives experienced by donating individuals towards making living donations of their organs may be reimbursed, removed, offset, or compensated for:
(i) surgical risk;
(ii) post-surgical inconvenience and discomfort;
(iii) long-term health risk; and
(iv) long-term health care costs.
If the phrase “incidental non-medical expenses” in the statute were deemed insufficient statutory authority to cover this proposal, we believe that 42 U.S.C. 274f1(b)’s language authorizing the Secretary of Health and Human Services to “make peer-reviewed grants or enter into peer-reviewed contracts … for the purpose of carrying out studies and demonstration projects to increase solid organ donation language about projects to increase organ donation… including living donation” would provide the necessary statutory authorization to remove disincentives more broadly than the narrow reimbursement contemplated by the existing NPRM.
The Phrase “Payer of Last Resort” Should Be Removed from the Regulation
3 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
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. The new draft regulation background section goes further and says on multiple occasions that “[t]he Program was designed to be the payer of last resort.”
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.
Expanding Donor Eligibility
While this draft regulation does not include changes to which donors are eligible to participate in the program, we still want to register suggestions for how to handle the future expansion of donor eligibility ordered by the President. First, currently, eligibility is determined not by the donor’s income but by the recipient’s income. This is irrational and unnecessarily cumbersome. If possible it should be changed. We recognize that the statute requires that the program not reimburse expenses that can reasonably be expected to be paid by the donor’s recipient, but first, we do not think that there is a particular income level at which this reasonable expectation kicks in. Second, there is no evidence that reimbursement of donors by their recipient varies by income level or is common at any income level. The eligibility guidelines are not the best way to implement this statutory restriction, which could be better accomplished by requiring donors sign a statement that they have not been reimbursed and cannot reasonably expect reimbursement from the recipient or another source.
Whether it is tied to a donor or a recipient’s income, the income threshold for eligibility should be significantly increased so that the program covers the vast majority of donors. The regulatory history here is instructive: the original NPRM in 2007 proposing donor eligibility standards set the limit at 200% of the poverty line. Public comments were unanimous that there should be no limit, so the limit was changed to 300%. In retrospect, this was too low, as NLDAC has repeatedly spent far less than the funds it was appropriated due to not having enough donors eligible. Additionally, the small number of donors eligible for the program has also constrained its adoption, which varies widely by center, with some large centers having less than 2% of donors utilize the program while the average utilization is 8%. If the public consistently recommends broad eligibility and HRSA’s guidelines consistently undershoot available funds, it would be arbitrary and capricious for the agency to limit the eligibility expansion ordered by the President.
We recommend an eligibility limit of 600% of the poverty line, which would allow most donors to be served by the program. The transplant-increasing and donor burden reducing benefits of reimbursement both justify a broad expansion. Additionally, in May, 2019, the Advisory Committee on Transplantation (ACOT) endorsed the National Living Donor Assistance Center’s recommendation of an increase in the eligibility to at least 500% of the poverty line. This
recommendation (and all other ACOT relevant ACOT recommendations) should be included in the language in the regulatory background describing ACOT’s recommendation.
Another NLDAC recommendation endorsed by ACOT was to make all non-directed donors eligible for the program. This should include any donors participating in Advanced Donation or “kidney voucher” programs. Currently non-directed donors are only eligible if their recipient has been determined and earns less than 300% of the poverty line. This is obviously irrational. Since non- directed donors definitionally do not know their recipient, it would be unreasonable to expect them to receive reimbursement from the recipient.
Finally, currently in order to be eligible for the program, both the donor and the recipient must be American residents. This requirement should be changed so that only the recipient must be an American resident. If a potential recipient has a donor from another country willing to donate (such as a family member), that donors’ expenses should be reimbursed. Donors should receive reimbursement from the federal governments because their gift benefits an American (and by extension the American public) – that is why it is logical for them to receive support. Whether or not they live in the United States themselves is immaterial to this calculus.
Urgency of Change
As mentioned above, we have significant concerns that the implementation of this policy is experiencing unnecessary delays. If (per the NPRM’s estimate), reimbursing this broader category of expenses would yield a 20% increase in donation (which would be about 1,400 transplants per year compared to 2019), that implies that each day of reimbursement equates to about four additional transplants. Therefore, the 73 days between the Executive Order’s deadline and the date the NPRM was published would, if it corresponds to a 73-day delay in program implementation, be expected to have caused the deaths of roughly 280 Americans on the waiting list who would otherwise have received a transplant. We cannot afford any more unnecessary delays.
We urge HRSA to move expeditiously to conclude all rule-making necessary to enact every element of the President’s Order and hope that significant planning is done ahead of time to ensure rapid implementation of the expanded reimbursement once the legal authority to do so is finalized.
APPENDIX A
Proposed Model Regulatory Language
The below draft model regulatory language was transmitted by the Coalition to Promote Living Donation to staff at the Department of Health and Human Services in April of 2019.
PROPOSED NLDAC AMENDMENTS
4.19.19
RATIONALE
Reimbursing the expenses of living organ donation has long been a consensus goal of the transplant community1 with support from groups like the American Society of Nephrology, American Society of Transplantation, the National Kidney Foundation, and Waitlist Zero.
The National Living Donor Assistance Center is authorized by statute to provide grants to reimburse donor expenses. A recent study found that for every dollar spent on NLDAC’s travel reimbursement program, Medicare saves $28 in dialysis costs due to the increase in transplantation.2 Expanding NLDAC through regulation to cover lost wages and other expenses like childcare and caretaker expenses could dramatically expand the impact of the program without requiring new authorizing legislation.
Based on previous studies of donor expenses and the impact of donor benefit policies, the expected per-donor cost of such a program would be roughly $4,000-$4,9003 and could realistically be expected to increase living donation rates by 15%-30% (see Evidence of Impact below). With a base rate of 6,000 donors in the status quo, that implies an increase of between 900 and 1,800 additional transplants each year for a total annual cost of $27.6M-$37.4M and net savings of $97M-$223M.4
Evidence of Impact: 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 quadrupled;5
1 See e.g., Rudow DP, Hayes R, Baliga P, et al. Consensus Conference on Best Practices in Live Kidney Donation: Recommendations to Optimize Education, Access, and Care. Am J Transplant. 2015 Apr; 15(4): 914–922. Salomon DR, Langnas AN, Reed AI et al. AST/ASTS workshop on increasing organ donation in the United States: creating an “arc of change” from removing disincentives to testing incentives. Am J Transplant. 2015 May;15(5):1173-9. An Open Letter to HHS Secretary Burwell on Ethically Increasing Organ Donation. Transplantation. February 2015 – Volume 1 – Issue 1 – p 1–19. Gaston R.S. Danovitch G.M., Epstein R.A. et al. Limiting Financial Disincentives in Live Organ Donation: A Rational Solution to the Kidney Shortage. Am J. Transplant 2006; 6: 2548–2555.
2 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.
3 See e.g. 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; 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; and 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.
4 Based on an estimated savings of $145,000 per transplant. Held PJ, McCormick F, Ojo A et al. A Cost-Benefit Analysis of Government Compensation of Kidney Donors. Am J Transplant. 2016 Mar;16(3):877-85.
5 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.
- A 2017 study of NLDAC travel reimbursement found a 14% increase in transplant at participating centers.6
- A 2015 study of state tax deductions for donor reimbursement found a 52% increase in donation to non-family members;7 and
- In a survey of NLDAC donors, 75% said they would not have donated without reimbursement.8
2. Donor Income Significantly Affects Transplant Rates
- Donation varies directly by income level9 – 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;10
SUMMARY OF CHANGES
- Qualifying Expenses: The expenses eligible for reimbursement by NLDAC are expanded to include all expenses incurred as a result of donation, including but not limited to “lost income (including demonstrated lost non-employment income); the economic value of limited sick or vacation days expended by the donor, childcare, eldercare, medications, care associated with the donor surgery, travel, lodging, meals and incidental expenses incurred by the donor and/or his/her accompanying person(s).” Instructions are provided for calculating lost income, childcare, and eldercare expenses.
- Income Eligibility: The recipient income eligibility cutoff is raised from 300% of the poverty line to 600% of the poverty line.
- Non-Directed Donors: Donors without a designated recipient would be deemed eligible for the program regardless of the income of their actual direct recipient.
- Donor Residence Requirement: Donors would not need to be U.S. residents or citizens to participate in the program.
6 Schnier K. Merion R. Turgeon N. et al. Subsidizing altruism in living kidney donation. Economic Inquiry 2018: Jan:56(1):398-423.
7 Bilgel, F and Galle, B, Financial incentives for kidney donation: A comparative case study using synthetic controls. 43 J. Health Econ 103 (2015). But see Boulware LE, Troll MU, Platinga LC, Powe NR. The association of state and national legislation with living kidney donation rates in the united states; a national study. Am J Transplant 2008; 8: 1451–1470, which finds no evidence of impact for state tax deductions.
8 See Warren, 2014 supra.
9 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. See also 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
10 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): 201–207.
AMENDED REGULATORY TEXT
National Living Donor Assistance Center (NLDAC) Program Eligibility Guidelines as Amended
Section 3 of the Organ Donation and Recovery Improvement Act (ODRIA), 42 U.S.C. 274f, establishes the authority and legislative parameters to provide reimbursement for travel and subsistence expenses incurred towards living organ donation. HRSA awarded a cooperative agreement to the Regents of the University of Michigan (Michigan), which partnered with the American Society of Transplant Surgeons (ASTS), to establish the National Living Donor Assistance Center (NLDAC) to operate this Program.
As provided for in the statutory authorization, this Program is intended to provide reimbursement only in those circumstances when payment is unlikely to be covered by other sources of reimbursement. The NLDAC, under Federal law, cannot provide reimbursement to any living organ donor for travel and other qualifying expenses if the donor can reasonably expect to receive reimbursement for these expenses from any of the following sources:
(1) any State compensation program, an insurance policy, or any Federal or State health benefits program;
(2) an entity that provides health services on a prepaid basis; or
(3) the recipient of the organ.
In previous rounds of public comment concerning this regulation, the majority of comments maintained that no threshold of income eligibility for the recipient of the organ should exist. In response, a threshold of income eligibility for the recipient of the organ is 600 percent of the Department of Health and Human Services (HHS) Poverty Guidelines in effect at the time of the eligibility determination. The Program assumes that recipients whose income exceeds this level will have the ability to reimburse the living organ donor for the qualifying expenses authorized by the Secretary of HHS. The Program provides an exception to this rule for financial hardships. A transplant social worker, or appropriate transplant center representative, based on a complete recipient evaluation, can provide an official statement, notwithstanding the recipient’s income level, that the recipient of the organ would face significant financial hardship if required to pay for the qualifying living organ donor expenses. A recipient’s financial hardship is defined as circumstances in which the recipient’s income exceeds 600 percent of the HHS Poverty Guidelines in effect at the time of the eligibility determination, but the individual will have difficulty paying the donor’s expenses due to other significant expenses. Whether or not hardship exists in a particular case requires a fact-specific analysis; examples of significant expenses include circumstances such as paying for medical expenses not covered by insurance or providing significant financial support for a family member not living in the household (e.g., elderly parent). Waiver requests by
the transplant center, on behalf of the recipient, shall be made in writing and shall
clearly describe the circumstances for the waiver request. The NLDAC will review waiver requests and make a recommendation to HRSA to either approve or deny the request.
HRSA will make the final determination and communicate its final determination to the
NLDAC. The NLDAC will notify the transplant center of the final determination. HRSA’s determination will not be subject to appeal.
All persons who wish to become living organ donors are eligible to receive reimbursement for their qualified expenses if they cannot receive reimbursement from the sources outlined above and if all the requirements outlined in the Criteria for Donor Reimbursement Section are satisfied. However, because of the limited funds available, prospective living donors who are most likely not able to cover these expenses will receive priority.
The ability to cover these expenses is determined based on an evaluation of (1) the donor and recipient’s income, in relation to the HHS Poverty Guidelines (described in Table 1.1 below), and (2) financial hardship. As a general matter, income refers to the donor or recipient’s total household income. A donor may be able to demonstrate financial hardship, even if the donor’s income exceeds 600 percent of the HHS Poverty Guidelines, if the donor will have difficulty paying the qualifying expenses due to other significant expenses. Although all requests will be reviewed on a case-by-case basis, examples of significant expenses include circumstances such as providing significant financial support for a family member not living in the household (e.g., elderly parent).
Waiver requests by the transplant center, on behalf of the donor, shall be made in writing and shall clearly describe the circumstances for the waiver request. The NLDAC will review waiver requests and make a recommendation to HRSA to either approve or deny the request. HRSA will make the final determination and communicate its final
determination to the NLDAC. The NLDAC will notify the transplant center of the final determination. HRSA’s determination will not be subject to appeal.
Donors will be given preference in the following order of priority:
Preference Category 1: The donor’s income and the recipient’s income are each 600 percent or less of HHS Poverty Guidelines in effect at the time of the eligibility determination in their respective states of primary residence.
Preference Category 2: Although the donor’s income exceeds 600 percent of the HHS Poverty Guidelines in effect in the State of primary residence at the time of the eligibility determination, the donor demonstrates financial hardship. The recipient’s income is at or below 600 percent of the HHS Poverty Guidelines in effect in the State of primary residence at the time of the eligibility determination.
Preference Category 3: Any living organ donor, regardless of income or financial hardship, if the recipient’s income is at or below 600 percent of the HHS Poverty Guidelines in effect in the recipient’s State of primary residence at the time of the eligibility determination.
Preference Category 4: Any living organ donor, regardless of income or financial hardship, if the recipient (with income above 600 percent of the HHS Poverty Guidelines in effect in the State of primary residence at the time of the eligibility determination) demonstrates financial hardship.
HRSA reserves the right for the grantee to prioritize those most in financial need (based on income or other specified factors) if it receives large numbers of applications concerning donors meeting preference category 1.
The HHS Poverty Guidelines for 2009 (Federal Register, Vol. 84, No. 22, February 1, 2019, pp. 1167-1168) are shown in the table below.
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Persons in family or
Deleted: 74…4, No. 14, Start Printed Page … [1]
Deleted: Hawaii
Formatted … [3]
Deleted: 10,830
Formatted … [2]
Formatted … [4]
Deleted: 13,530
Formatted … [5]
household
|
1
|
2
|
3
|
4
|
5
|
6
|
7
8
For each additional person, add
4,420
Hawaii
|
|
|
$14,380 19,460
|
24,540
|
29,620
|
34,700
|
39,780
|
44,860
49,940
$5,080
Deleted: 12,460
Formatted … [6]
Deleted: 14,570
Deleted: 18,210
Deleted: 16,760
Formatted … [7]
Deleted: 18,310
Deleted: 22,890
Deleted: 21,060
Formatted … [8]
Deleted: 22,050
Deleted: 27,570
Deleted: 25,360
Formatted … [9]
Deleted: 25,790
Deleted: 32,250
Deleted: 29,660
Formatted … [10]
Deleted: 29,530
Deleted: 36,930
Deleted: 33,960
Formatted … [11]
Deleted: 33,270
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These guidelines are updated periodically.
Criteria for Donor Reimbursement
- Any individual who in good faith incurs qualifying expenses toward the intended donation of an organ.
- The recipient of the organ is a U.S. citizen or lawfully admitted resident of the U.S.
- The recipient has primary residence in the U.S. or its territories.
- For the purpose of reimbursement toward travel expenses, travel is originating from the donor’s primary residence.
- Donor and recipient certify that they understand and are in compliance with Section 301 of NOTA (42 U.S.C. 274e) which states in part “* * * It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human organ for
Deleted: 41,610
Deleted: 38,260
Formatted … [12]
Deleted: 37,010
Deleted: 46,290
Deleted: 42,560
Deleted: 3,740
Deleted: 4,680
Deleted: 4,300
Deleted: travel and other
Deleted: Donor andThe recipient of the organ ar..e.…[1s 3a] Deleted: Donor andThe recipient have…as prim.a.r. y[14] Deleted: 4. Travel
valuable consideration for use in human transplantation if the transfer affects interstate commerce.”
- The transplant center where the donation procedure occurs certifies to its status of good standing with the Organ Procurement and Transplantation Network (OPTN).
Qualifying Expenses
For the purposes of the Reimbursement of Travel and Subsistence Expenses toward Living Organ Donation Program, qualifying expenses refers to all reasonable expenses incurred in the act of donating an organ, which include but are not limited to lost income (including demonstrated lost non-employment income); the economic value of limited sick or vacation days expended by the donor, childcare, eldercare, medications, care associated with the donor surgery, travel, lodging, meals and incidental expenses incurred by the donor and/or his/her accompanying person(s) as part of:
(1) Donor evaluation and/or
(2) Hospitalization for the living donor surgical procedure, (3) The 4-8 weeks of recovery following surgery; and/or
(4) Medical or surgical follow-up, clinic visits, or hospitalization within 5 calendar years following the living donation procedure connected to donation (or beyond the 5-year period if exceptional circumstances exist).
With regards to travel, the Program will pay for a total of up to five trips; three for the donor and two for accompanying persons. However, in cases in which the transplant center requests the donor to return to the transplant center for additional visits as a result of donor complications or other health related issues, NLDAC shall provide reimbursement for the additional visit(s) for the donor and an accompanying person.
The accompanying persons need not be the same in each trip.
The total Federal reimbursement for qualified expenses during the donation process for the donor and accompanying individuals shall not exceed $14,000.00. Reimbursement for qualifying travel expenses shall be provided at the Federal per-diem rate, except for hotel accommodation, which shall be reimbursed at no more than 150 percent of the Federal per diem rate.
For kidney donors who experience lost income, the calculation of such income shall be derived from an average of all income received for a three-month period sampled by the eligibility questionnaire with such period not to exceed twelve months before the actual donation. The total period of time related to lost wages or expended sick or vacation days shall not exceed four weeks for donors whose employment does not require physical labor unless special circumstances are demonstrated. The total period of time related to lost wages or expended sick or vacation days shall not exceed ten weeks for donors whose employment does require physical labor unless special circumstances are demonstrated.
Whether or not special circumstance exist in a particular case requiring extension of the reimbursement window requires a fact-specific analysis. Waiver requests by the transplant center, on behalf of the recipient, shall be made in writing and shall clearly describe the circumstances for the waiver request. The NLDAC will review waiver
requests and make a recommendation to HRSA to either approve or deny the request. HRSA will make the final determination and communicate its final determination to the NLDAC. The NLDAC will notify the transplant center of the final determination. HRSA’s determination will not be subject to appeal.
For eldercare or childcare expenses that constitute qualifying expenses, the rate for reimbursement shall not exceed 150% the prevailing local cost of such services in the donors’ residence.
Qualifying expenses shall be reimbursed as close in time as possible to their being incurred by the donor, including by pre-payment where practicable.
For donor and recipient pairs participating in a paired exchange program, the applicable eligibility criteria for the originally intended recipient shall be considered for the purpose of reimbursement of qualifying donor expenses even though the final recipient of the donated organ may not be the recipient identified in the original donor-recipient pair.
Given the utilization of non-directed donors in transplant chains of multiple recipients, one or more of whom are very likely to fall within the income threshold and given that it is unreasonable to expect a recipient to cover such donors’ expenses where no recipient has yet been identified, donors without a designated recipient otherwise entitled to reimbursement under this program will be deemed eligible notwithstanding the income of their actual, direct recipient. Donors participating in an advanced donation program (a.k.a. a “kidney voucher”) program shall be deemed to be non-directed donors.
Maximum Number of Prospective Donors per Recipient
- Kidney: two donors at a time with a maximum of five donors
- Liver: two donors at a time with a maximum of five donors
- Lung: two donors at a time with a maximum of six donors
Special Provisions
Many factors may prevent the intended and willing donor from proceeding with the donation. Circumstances that would prevent the transplant or donation from proceeding include: Present health status of the intended donor or recipient, perceived long-term risks to the intended donor, justified circumstances such as acts of God (e.g., major storms or hurricanes), or a circumstance when an intended donor proceeds toward donation in good faith, subject to a case-by-case evaluation by the NLDAC, but then elects not to pursue donation. In such cases, the intended donor and accompanying persons may receive reimbursement for qualified expenses incurred as if the donation had been completed. Under Program policy, a form will be filed with the Internal Revenue Service (IRS) reporting funds disbursed as income for expenses not incurred.
APPENDIX B
Coalition to Promote Living Donation Meeting Request Letter to HRSA
Frank Holloman Acting Director
Division of Transplantation
Health Resources and Services Administration 5600 Fishers Lane
Rockville, Maryland 20857
Cc: Cheryl Dammons, Dr. George Sigounas
June 18, 2019
Mr. Holloman,
We, the Coalition to Promote Living Donation, were thrilled to see the announcement in the Office of Information and Regulatory Affairs Spring Uniform Agenda that a Notice of Proposed Rulemaking to expand expenses reimbursable by the National Living Donor Assistance Center would be issued at the beginning of September. While we would like the NPRM to be issued earlier this summer, we feel positively about this public commitment to NLDAC expansion over a short time frame, combined with the Advisory Committee on Transplantation’s recent endorsement of expanding NLDAC to reimburse lost wages, childcare, and eldercare, loosening the income cap, and making non-directed donors eligible for the program.
It is clearly an exciting time for those of us interested in expanding access to living organ donation, and to that end our Coalition would like to request a meeting to be held early in the summer with you and your team at the Division of Transplantation and the Healthcare Systems Bureau. The meeting would address HRSA’s role in the future of live organ donor transplant policy along with identifying and removing any last concerns or obstacles preventing HHS from immediately issuing an NPRM expanding the living donor reimbursement program along the lines recommended by NLDAC and endorsed by ACOT. In mid-April, we submitted model regulatory amendment language to this end, which our coalition endorses, but as we have said repeatedly, the specific language is less important than that an NPRM is issued and issued immediately. In an ideal world, this NPRM could be issued before this early summer meeting between our Coalition and HRSA, but we understand if there are some last details and concerns that need to be addressed.
While we are excited for the announced NLDAC expansion, there are concerns that we and HRSA do not share the same timeline: from lag time in HRSA support of expanding donor reimbursement despite support from major stakeholders and hundreds of donors in 2014 to the recent failure to include all comments in the ACOT meeting, despite assurances from HRSA staff. Living donors cannot afford the delays seen in implementing the Kidney Allocation System (twelve years from start
to finish), NLDAC (three years from statutory authorization to implementation), and the Liver Allocation System (ongoing).
We come to this meeting with a sense of enthusiasm because we feel the future of HRSA and living donation is a bright one. We admire the dedication and hard work HRSA has put into meetings like the transplant innovation workshop held in fall of 2016 and appreciate the Division of Transplantation’s role as a convener. We have assembled a NLDAC expansion petition signed by public intellectuals, leading transplant figures, and hundreds of kidney donors that we plan to formally present when we meet. We feel a public meeting with the relevant Division of Transplantation leadership, centered around living donors and scheduled for early July, would be a great venue to reify HRSA’s commitment to NLDAC expansion and develop together further grounds for expanding living donation that could help the field flourish for years to come.
Sincerely,
The Coalition to Promote Living Donation
Alliance for Paired Donation American Transplant Foundation
Bay Area Association of Kidney Patients Donor to Donor
Foundation for Kidney Transplant Research The John Brockington Foundation
Kidneys in Common The Kidney Connection
Kidney Donor Conversations Living Bank
Living Kidney Donors Network Northeast Kidney Foundation Transplant Support Organization Waitlist Zero
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