National Living Organ Donor Assistance Center (NLDAC)

I've recently joined the advisory board of the National Living Organ Donor Assistance Center (NLDAC), which gives certain forms of financial assistance--mostly travel assistance--to living organ donors.  I expect to learn more about what they do, and can do, in the months to come.

Here's a page outlining how to apply for travel assistance.

And here's a paper describing its history and experience:
Development of the National Living Donor Assistance Center: reducing financial disincentives to living organ donation, by
Patricia H. Warren, RN, CPTC, Kimberly A. Gifford, MBA, Barry A. Hong, PhD, Robert M. Merion, MD, and Akinlolu O. Ojo, MD, PhD, MBA

Abstract: Over the years, the transplant community has worked to advance the care of living organ donors; however, barriers remain, including the nonmedical expenses incurred by living donors. A new center, funded by a grant from the Health Resources and Services Administration (HRSA), was established to operate a nationwide system to remove these financial disincentives. The HRSA grant was awarded to an academic institution and the daily operations are managed by a transplant professional society. Expenses are reimbursed prospectively for financially needy living donors. Combining the legislative authority and economic resources of the federal government, the research experience of an academic institution, and the management know-how of a professional society has proven to be successful. To date, the center has received 3918 applications submitted by 199 different transplant centers and receives about 80 applications per month. On average, a donor spends $2767 for their travel expenses to the transplant center. Of the 3918 applications that have been submitted, 1941 of those applicants (50%) have completed their donor surgery.

There's no consensus on incentives for kidney donation, but maybe there is on removing disincentives

The discussion of whether there should be incentives for organ (particularly kidney) donation remains heated. But there seems to be a growing consensus that removing financial disincentives is important, ethical, and do-able. Here's a paper that I presume will be published jointly with the one in my previous post.

Living and Deceased Organ Donation Should Be Financially Neutral Acts
F. L. Delmonico, D. Martin, B. Domínguez-Gil, E. Muller, V. Jha, A. Levin, G. M. Danovitch andA. M. Capron
Article first published online: 31 MAR 2015
DOI: 10.1111/ajt.13232

"Introduction: The supply of organs—particularly kidneys—donated by living and deceased donors falls short of the number of patients added annually to transplant waiting lists in the United States. To remedy this problem, a number of prominent physicians, ethicists, economists and others have mounted a campaign to suspend the prohibitions in the National Organ Transplant Act of 1984  (NOTA) on the buying and selling of organs. The argument that providing financial benefits would incentivize enough people to part with a kidney (or a portion of a liver) to clear the waiting lists is flawed. This commentary marshals arguments against the claim that the shortage of donor organs would best be overcome by providing financial incentives for donation. We can increase the number of organs available for transplantation by removing all financial disincentives that deter unpaid living or deceased kidney donation. These disincentives include a range of burdens, such as the costs of travel and lodging for medical evaluation and surgery, lost wages, and the expense of dependent care during the period of organ removal and recuperation. Organ donation should remain an act that is financially neutral for donors, neither imposing financial burdens nor enriching them monetarily.
...
Pilot Experiments of Financial Incentives Are Fundamentally Wrong
"Proponents of financial incentives claim to be merely seeking pilot programs to test their proposals [2, 4]. However, an experiment that abandons a moral principle—in this case, the principle that the human body as such should not be treated as an object of commerce—cannot preserve that principle. There is no reason to perform the experiment unless the result can affect subsequent decisions; thus, conducting an experiment with organ payments only makes sense if policymakers are willing to suspend the prohibition on paying for organs as a permanent matter.

"Suspending the prohibition on organ sales for a certain period so a trial can be conducted would make reinstatement of the prohibition difficult to accomplish. Assuming that any trial would need to be conducted for a number of years to provide reliable information, the basic attitude of the population toward donation would be reshaped during the trial period towards an expectation of financial rewards and hence commercialized “donation.” If as a consequence, paying donors crowds out altruistic donation [10], such effects would likely persist after the pilot trial [11]. Moreover, if the benefits offered do not produce enough organs, the proponents are unlikely to abandon their efforts but will rather lobby to increase the value of the incentive and try again. Taking on the risks involved in such experiments seems difficult to defend, since the donation rates in countries that have prohibited payment exceed those in countries where payment is legal or tolerated. The latest confirmation of the deleterious effect of payment comes from the marked rise in living related and deceased donation in Israel following the enactment in 2008 of a law ending the practice of paying for Israelis to go to countries where they could get transplants with purchased kidneys [12].

"If pilot experiments of payments to organ donors are conducted in the United States, it would foster the resumption of programs of financial “gratuities” in the Philippines, India, Pakistan and Egypt where “the intersection of a high poverty level (which translates to a large number of individuals susceptible to exploitation) and a high corruption index (which translates to a high likelihood that exploitation of the vulnerable would occur)” [13].

"Finally, the advocates have never explained the details of such experiments—their length, the jurisdictions that would be involved, the comparator (historical data vs. an active “control” group in the same or another jurisdiction that would still be subject to existing law), or the metrics by which the results would be evaluated.

Removal of Disincentives to Donation Should Be a Priority
"The energies directed to the debate about financial incentives would be better utilized in finding ways to remove barriers to organ donation, in particular financial disincentives. For example, it has been estimated that living donors in the United States may incur on average $6000 or more in costs for travel expenses and lost wages [14]. During the recent recession, the rate of living kidney donations decreased in the United States because some potential donors could not afford to bear such expenses [15] and were either unaware of, or did not meet the requirements for, programs that (due to limited funding) cover some of but not all of donors' financial costs and losses [14].

"The removal of financial disincentives is not only ethically preferable but is also recognized as legitimate by the WHO Guiding Principles [16], other international standards [17, 18] and the laws in many countries [19], which differentiate between paying money for an organ as such and reimbursing donors for the expenses and financial losses they bear as a consequence of their gift. The costs of the potential donor's care from predonation screening to postoperative recovery, lost wages and the costs of care for those dependent upon the donor should be borne by whichever entity is paying for the transplant procedure (private insurance, Medicare, Medicaid, etc.). The payments may be made directly from that entity or through the transplant program but in no case should they come directly from the organ recipient. Financial provision should also be made for the maintenance of long-term follow up and treatment of any conditions related to the nephrectomy or partial hepatectomy, including any costs not covered by the donor's medical insurance. The aim should be to provide coverage to ensure the donor does not suffer an economic loss from medical complications.

"The Live Donor Community of Practice (LDCOP) of the American Society of Transplantation (AST) has recognized the need to identify effective strategies to improve access to LDKT/LKD and improve LKD education and evaluation processes. The LDCOP has suggested that “Expansion of the National Living Donor Assistance Center (NLDAC) is likely to have the most immediate and substantial impact on attenuating financial disparities in LKD” [20].

"Thus, if a donor's medical insurance does not provide complete coverage of costs related to the donation procedure, the additional insurance could be administered by the existing NLDAC and provided by the entity that is paying for the transplant procedure [21]. This can be done without creating a financial incentive of the sort that would arise were donors given general medical insurance that they would otherwise lack. We recognize that NLDAC does not currently provide for this donor insurance; so we have requested that a Task Force be convened by HHS Secretary Burwell to develop pilot programs for removing these financial obstacles to organ donation [22]. Complications related to the donor nephrectomy or partial hepatectomy are not difficult to identify. They include for example perioperative infections (wound, urinary tract, or pneumonia), an extremity deep vein thrombosis, depression in the weeks following the donation and conditions of later onset which treating physicians may attribute to the donor surgery, such as an intestinal obstruction. The LDCOP is reportedly underway with drafting codes of organ donor complications (such as ICD codes used by CMS).

"Donors should also be provided with life insurance to cover death as a result of being a living donor. The death should be attributable/associated with the donor procedure; and would be a readily recognizable complication of bleeding, pulmonary embolism, myocardial infarction, or sepsis (as has occurred following living liver donation).

"Discrimination against donors seeking to purchase their own health and life insurance has been reported [23] and must be outlawed.

"Making available reimbursement for the actual costs or losses incurred, regardless of donors' financial resources, would not enrich them but merely make donating a kidney a financially neutral act. Similarly, the families of deceased organ donors should not have to pay any expenses generated by posthumous donation, such as costs related to the evaluation of potential donor and organ suitability, or prolongation of the donor's time in an ICU to enable postmortem donation. Since covering expenses leaves living donors and the families of deceased donors in neither a better nor a worse financial situation than they would have been had they not taken part in the process of donating organs, there would be no need to modify NOTA's prohibition on paying for organs. When combined with the removal of other systemic barriers to donation and adoption of best practices in living donation, as recently recommended by the LDCOP [20], eliminating financial disincentives should produce a substantial and sustainable increase in the rate of kidney donation as experienced in Israel, but is also being implemented in Australia, Canada, and the Netherlands [12]."

Four recent calls for removing disincentives for organ donation

There are a number of efforts underway to reduce the financial dis-incentives to kidney donation, with more or less emphasis on opposition to, and how removing dis-incentives is different from, compensating donors.

The first I'll mention is a March 13 blog post from Kenneth A. Newell, the president of the American Society for Transplantation:  Why all the talk about incentives?
Here's his whole post:

Last summer, the ASTS and the AST held a workshop to discuss the financial barriers faced by living organ donors. All of us who are engaged in the practice of living donor transplantation realize that the entire healthcare delivery system (providers, hospitals, insurers, and the government), as well as the recipient and society as a whole, benefits financially from the practice of living donation. Disturbingly, the donors are the group most at risk for adverse financial events. In many cases, donors incur expenses related to travel, meals, and lodging, as well as lost wages. In addition to these concrete financial consequences, living donors also face very real concerns about the loss of employment and the impact their donation will have on future insurability. Programs such as the HRSA-funded National Living Donor Assistance Center (NLDAC) provide critical support to those donors with the most extreme financial need, but this support is limited to travel and travel-related expenses.

The aim of the first meeting was to explore whether the AST and the ASTS could articulate a common vision on the topic of financial disincentives and incentives as they pertain to organ donation. The two societies agreed to work to remove all financial disincentives to organ donation, and consider pilot projects to study what some might consider to be true incentives. These ideas are more fully articulated in a New York Times editorial authored by Daniel Salomon and Alan Langnas, as well as in a manuscript soon to be published in the American Journal of Transplantation.

As a second step, representatives of the two societies met last month in Minneapolis to discuss how the goals articulated at the first meeting could be operationalized. Presentation topics included the perspective of payers, overviews of NOTA and NLDAC, and consideration of how changes to NOTA could be effected. Attendees discussed where the societies might draw the line between the removal of disincentives and the provision of true incentives for living organ donation, and how an expanded program to remove all disincentives for all living donors might be administered (assuming that funding could be obtained). This second meeting focused almost entirely on the removal of financial disincentives with the goal of making the donor financially whole. This position was recently advanced by the AST Best Practices in Living Donation Consensus Conference. At this second meeting, there was little discussion about incentives or pilot projects to test the impact of true incentives, as these are more controversial and will require substantially more effort and time to engage a broader set of transplant stakeholders. In other words, both the AST and the ASTS agreed that the task of operationalizing the original workshop’s ideas must be strictly pragmatic and start with those changes that are largely agreed upon now: removing all disincentives.

So why all of the talk about incentives (and disincentives)? Because any changes to the current financial practices of organ donation will require the AST and the ASTS to engage in ongoing discussions with a larger set of stakeholders: patient groups, transplant professionals, government leaders, and society as a whole. Any changes must have the support of these groups as well as our membership, and any changes must meet the real needs of patients, donors and their families.

Over the next several months, the AST will reach out to our membership and these other groups to discuss the removal of financial disincentives, the definition of true incentives, and the challenge of possibly testing incentives in pilot projects. The conversation starts here: please share your opinions in the comment section.

Next, the open letter linked and excerpted below, is from the Declaration of Istanbul Custodian Group and signed by many prominent opponents of compensation to donors: the first signer is Frank Delmonico.
An Open Letter to HHS Secretary Burwell on Ethically Increasing Organ Donation

"In 1984, Congress passed the National Organ Transplant Act (NOTA). That statute not only established the Organ Procurement and Transplantation Network but also enshrined in law a principle that had guided the development of organ transplantation worldwide over the previous 30 years: organs from living and deceased donors are precious gifts, and should not be bought and sold as market commodities.

Remove the Obstacles to Donation

The growing demand for transplants currently exceeds the supply of donated organs. In the previous decade, a collaborative effort among the Department of Health and Human Services, organ procurement organizations, physicians, and community groups produced a 25% increase in the number of deceased donor organs. Yet, over the course of the past ten years in the United States, the number of kidney transplants (which account for more than two thirds of all transplants) made possible by living donors has declined by approximately by a thousand.One major reason for this decline is that living donors in the United States incur on average more than U.S. $6000 in out-of-pocket costs. Potential donors may not be able to afford these expenses and may either be unaware of, or not meet the strict requirements for, programs that cover some but not all of donors' financial costs and losses.If the United States wants to increase organ donation, we should begin by removing these financial disincentives. We are aware that some people have recently called on the President and Congress to repeal, or at least suspend, NOTA's prohibition on paying organ donors. However, when it looked at “Ways to Reduce the Kidney Shortage” (September 2, 2014), the New York Times rightly concluded that “there are lots of reforms that could be made without resorting to paying for kidneys.”

The post goes, on, you should read the whole thing, but here are the two concluding section heads:
Appoint a New Task Force on Organ Donation and Transplantation
and
Financial Incentives for Donation Would Violate Global Standards and Will Not Work
****************

Below is a statement from an organization whose very name reflects the complicated politics: it is called STOP ORGAN TRAFFICKING NOW!, and it describes its goal as "Working to Remove Barriers to Living Donations". That is, it is an organization seeking to remove disincentives to donation, that wants to distinguish itself from black markets, and perhaps from those proposing compensation. (Forming coalitions is hard, and politics is incremental...)

The SOTN Proposal In Simplest Terms
"• Increase penalties for organ brokering at home and abroad.
• Follow original intent of NOTA and have Medicare help patients in greatest medical need first and according to UNOS current wait list criteria by:
(a) paying expenses of donors willing to give to top match in their region, and
(b) paying the Organ Procurement Organizations (OPOs), which currently match deceased donor organs with recipients, to arrange living matches as well.
• Allow 501(c)(3) public charities (and recipients themselves) to cover all donation related expenses – The same expenses that currently can be deducted from state income taxes at the state level. Charities can help any donor, not just those giving to front of the list.
• Create living donor registry that puts donor AND one relative to the front of the list at any time donor chooses."
**************

Finally, I'm keeping an eye on a newly formed organization called Waitlist Zero, in part because its co-founder and executive director is Josh Morrison, a young lawyer and kidney donor (who thinks of kidney donation as an example of effective altruism), with whom I had the privilege to work when he was the general counsel at the Alliance for Paired Donation (Mike Rees' kidney exchange organization).

Here is their statement of goals, principles and policies:

Our Goals. We come together as a coalition to advocate that the Health Resources and Services Administration:

1. Publicly support the goal of increasing living kidney donation;
2. Allow grant funding, including that pursuant to 42 U.S. Code §274f–1(b), to go to projects intended to increase living kidney donation;
3. Allocate such funds in rough parity between living and deceased donation projects; and
4. Include metrics and goals related to the increase of living donation on HRSA’s FY 2016 Annual Performance Report.

Our Principles. Collectively, the Coalition believes:

• Deceased donation alone can never end the deadly kidney shortage, and any policy that takes that shortage as given is morally unacceptable.
• Living donation is a noble choice that is not right for everyone, but donors themselves can benefit from the better health of their loved ones and the psychic gains to donation. Since studies show the vast majority of living donors do not regret donating, federal policy should presume donation to be a positive choice worth promoting.
• Informed consent must be maintained for every kidney transplant. Any effort to coerce or pressure someone into donating is unacceptable.
• Improvements are always possible, but the current transplant system does an excellent job of ensuring informed consent for the thousands of living donors who give each year.
• Government programs to increase living donation should not and will not impinge on the ability of transplant centers to ensure informed consent and guarantee the absence of coercion.

Our Policies. Collectively, the Coalition hopes that HRSA’s support for increasing living kidney donation will lead to policies along the lines of the following:

• Donors should not be worse off for having donated. Government should: (1) guarantee the reimbursement of donor lost wages, (2) provide health insurance coverage to alleviate risks of donation, and (3) devote appropriate resources to ensure long-term donor follow-up.
• Transplant awareness and education should be increased for the public, patients, and patient families. All patients and patient families should receive comprehensive transplant education before they go on dialysis (when possible) and immediately thereafter (when necessary). Access to paired kidney donation should be universal.
• Members of the Coalition may have different views as to the advisability of incentives for living donation, but the Coalition believes there are many ways the federal government can increase living donation that do not raise the controversy of incentives, and this campaign is not intended to promote the adoption of incentives.

HT: Frank McCormick, et al.

Many groups are starting to advocate experiments on compensating organ donors

There's a lot of discussion these days about clinical trials of incentives for organ donation as a way of increasing supply.

Here's a blog post from the AST, the American Society of Transplantation, on removing financial disincentives:  The Cost of Giving

" it is increasingly obvious that we impose on donors’ financial risk, a concept that threatens our perceptions of donation as an altruistic act. Gill et al (JASN, 2014 Jul 17, epub) documented, in the recent economic downturn, greatest decline in living donation among those most challenged socioeconomically, indicating the role of financial risk in discouraging “altruistic” donors.
All this is occurring against a backdrop of intense controversy regarding “incentives” for donation that has raged for years, incorporating both national and global perspectives on ethics, economics, black markets, free markets, and so on. Amidst so much controversy, though, some light is beginning to emerge. Strong ethical and economic arguments can be advanced for and against incentives. The Declaration of Istanbul outlines important precepts that address unethical practices, including underground markets, on a global basis. However, in the United States, with a well-developed organ recovery infrastructure and rule of law, examples from the underground market (as were the basis of a recent New York Times expose) may be less relevant. There is emerging support in the US for a regulated infrastructure that could address the financial implications of organ donation. The National Living Donor Assistance Center (NLDAC) already offers limited assistance for those means-tested as unable themselves to underwrite the cost of donation. Extending assistance to eliminate all financial costs regardless of means, including access to healthcare, is now considered a mainstream view (far from the reception for a similar proposal from a small working group eight years ago: Gaston et al, AJT 6: 2548, 2006).
...
"Participants in two recent meetings (both held in Chicago in June and sponsored in part by AST) will soon be publishing white papers that seek to clarify the discussion regarding compensation of living donors in the US. It is obvious that a great deal can be done within NOTA to remove disincentives (as both white papers are likely to endorse). In medicine, it is usually desirable to address controversy with evidence, as might be obtained via limited demonstration projects of targeted incentives. Though these would likely require amendment of NOTA, such has already occurred twice with the Charlie Norwood and HOPE acts, both crafted in response to a changing environment and both endorsed by AST. Our task, if we are to do everything possible for our wait-listed patients and protecting all the interests of potential donors, is to make sure we get the nuances right."


And here is an open letter, signed by a variety of interested parties
HOW TO END THE WAIT FOR ORGAN TRANSPLANTS

"We support current efforts to prevent diabetes and hypertension and to make the donation process fairer and more efficient, but they will not resolve the shortage. Additional approaches must be tried. Sadly, transplant policy has been governed by an unsubstantiated assumption: that donors cannot receive benefits for donating without being exploited or coerced. It is critical to examine that assumption. We hereby call for the swift initiation of evidence-based research on ways to offer benefits to organ donors in order to expand the availability of transplants."

Why it's hard to reimburse non-directed kidney donors for their travel costs

A letter to the editor of the American Journal of Transplantation:

To the Editor:

We are responding to the Melcher et al. [1] article, which recommends that the National Living Donor Assistance Center (NLDAC) pay for travel and lodging for nondirected donors (NDDs). We commend the work done by this group of stakeholders and believe the publishing of their findings is vital to improving the process of kidney paired donation. We do, however, need to clarify one point in their many important recommendations.

The article recommends “The National Living Donor Assistance Center should provide travel and lodging expenses to the NDD.” It is important to note that there are limits to the NLDAC program that were put in place by the U.S. Congress. NLDAC cannot pay for the travel and lodging expenses for all NDDs. The Organ Donation Recovery and Improvement Act (ODRIA) [2] established the legislative parameters for NLDAC. ODRIA states that individuals may not receive compensation from the grant if these expenses can reasonably be paid by a State or Federal program, an insurance company or the recipient of the organ. ODRIA requires means testing of the recipient's household income.

In practice, this means a recipient must be identified before an application can be filed with NLDAC. Because NDDs do not have a recipient identified before their evaluation trip to transplant center, NLDAC cannot reimburse those expenses. However, after a recipient is identified, a NLDAC application may then be filed. It should be noted that NLDAC received 42 applications between 2008 and 2012 for NDD, of which 32 were approved, providing NDDs with reimbursement of travel expenses through NLDAC.

If the recipient's household income is below the income threshold of 300% of the HHS Poverty Guidelines, NLDAC is allowed to reimburse those donor's expenses for the surgery and medical follow-up trips. If the recipient's income is above the income threshold, NLDAC may reimburse the donor's expenses if financial hardship is proven by the recipient. If the application is not approved, the National Organ Transplant Act (NOTA) [3] allows the recipient to reimburse the donor's expenses.

Lastly, we agree with the article's recommendation that payers should cover donor travel and lodging costs given that, by donating and traveling, the donor is enabling not only the recipient's transplant, but also those of other recipients.

This letter represents the views of the authors and does not necessarily represent the views of the grant funder.

A. O. Ojo1*, R. M. Merion2, D. H. Howard3 and P. H. Warren4
1Division of Nephrology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan
2Division of Transplantation, Department of Surgery, University of Michigan, Ann Arbor, Michigan
3Department of Health Policy and Management, Emory University, Atlanta, Georgia
4National Living Donor Assistance Center, American Society of Transplant Surgeons, Arlington, Virginia
*Corresponding author: Akinlolu Ojo, aojo@med.umich.edu
 The letter is found under the heading
Response to “Dynamic Challenges Inhibiting Optimal Adoption of Kidney Paired Donation: Findings of a Consensus Conference” by Melcher et al.
American Journal of Transplantation, Volume 13, Issue 8, page 2228, August 2013