Surgery Grand Rounds at UCSF. "Kidneys and Controversies: Kidney Exchange Within and Across Borders" Oct 21 (7am PST)

 Tomorrow at dawn I'll give a seminar to the surgeons at UCSF, about kidney exchange, and the controversies it has overcome, and is overcoming.

Surgery Grand Rounds | Kidneys and Controversies: Kidney Exchange Within and Across Borders

Date: October 21, 2020 Time: 7:00am-8:00am Place: Webinar

Rishwain Visiting Speaker: Alvin E. Roth, PhD

Al Roth is the Craig and Susan McCaw Professor of Economics at Stanford University and the George Gund Professor Emeritus of Economics and Business Administration at Harvard University. He shared the 2012 Nobel memorial prize in Economics. His research interests are in game theory, experimental economics, and market design. In the 1990’s he directed the redesign of the National Resident Matching Program (NRMP) and currently is a member of the Board of Directors. He has been involved in the design and organization of kidney exchange, which helps incompatible patient-donor pairs find life-saving compatible kidneys for transplantation. He is on the Advisory Board of the National Living Donor Assistance Center (NLDAC). His work on kidney transplantation led him to become interested in repugnant transactions, and more generally how markets, and bans on markets, gain or fail to gain social support.

The University of California, San Francisco School of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.  CME Course MGR21045

UCSF designates this live activity for a maximum of 43 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

*The above credit is inclusive of credit for all Fiscal Year 2020-2021 Department of Surgery Grand Rounds.

Disclosure declaration – No one in a position to control the content of this activity has a relationship with an ACCME-defined commercial interest. Planners  Wen Shen, MD, Julie Ann Sosa, MD, MA, Lygia Stewart, MD, and Ryutaro Hirose, MD, have stated that they have no relationships to disclose. Speaker Roth has stated that he has no relevant relationships to disclose.

This activity is supported by the Department of Surgery’s Howard Naffziger Endowment Fund.

Join Webinar: https://ucsf.zoom.us/j/252447171?pwd=MWt0bG9vTjBSZEo1UnpidXRVWWU2UT09 

Removing financial disincentives to living organ donation: HRSA publishes Final Rule

 The Health Resources and Services Administration (HRSA), Health and Human Services Department (HHS) has published its Final Rule in the Federal Register

Removing Financial Disincentives to Living Organ Donation--A Rule by the Health and Human Services Department on 09/22/2020

"SUMMARY: This final rule amends the regulations implementing the National Organ Transplant Act of 1984, as amended (NOTA), to remove financial barriers to organ donation by expanding the scope of reimbursable expenses incurred by living organ donors to include lost wages, and child-care and elder-care expenses incurred by a caregiver. HHS is committed to reducing the number of individuals on the organ transplant waiting list by increasing the number of organs available for transplant. This final rule is associated with Section 8 of the Executive Order (E.O.) 13879 titled “Advancing American Kidney Health,” issued on July 10, 2019, which directed HHS to propose a regulation allowing living organ donors to be reimbursed for related lost wages, child-care expenses, and elder-care expenses through the Reimbursement of Travel and Subsistence Expenses Incurred toward Living Organ Donation program authorized under section 377 of the Public Health Service (PHS) Act, as amended."

...

"The National Living Donor Assistance Center (NLDAC) [4] operates the living organ donor reimbursement program funded by HRSA's Reimbursement of Travel and Subsistence Expenses Incurred toward Living Organ Donation grants program. Under the authority provided under section 377 of the PHS Act, as amended, the program is operated via cooperative agreement. The program's purpose is to help remove financial disincentives for living organ donations. In adherence to the authority outlined in the PHS Act, the program's Eligibility Guidelines currently provide that “qualifying expenses” include those incurred by the donor and his/her accompanying person(s) as part of: (1) Donor evaluation, (2) hospitalization for the living donor surgical procedure, and/or (3) medical or surgical follow-up, clinic visits, or hospitalization within two calendar years following the living donation procedure.

...

"Through this final rule, the Secretary determines that reimbursement for lost wages, and child-care and elder-care expenses incurred by a caregiver, is appropriate for living organ donors who incur such expenses toward their organ donation."

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The final rule authorizes the National Living Donor Assistance Center (NLDAC) to expand the category of expenses that it can reimburse, for those who meet its income and other conditions.

I'm on NLDAC's Advisory Board, and at the present time I haven't heard that NLDAC's budget will be increased to fund the expanded expenses it is now permitted to reimburse.

Lost Wages Support for Living Organ Donors Demonstration Project

HRSA (the Health Resources & Services Administration) has now funded a
Lost Wages Support for Living Organ Donors Demonstration Project.

It will be run by a consortium of organizations and administered through NLDAC (the National Living Donor Assistance Center).

NLDAC has also been running a randomized control trial sponsored by the Arnold Foundation:
Effect of Lost Wage Reimbursement to Kidney Donors on Living Donation Rates

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This is a developing story:)
Here are some of my earlier related posts

Tuesday, July 16, 2019

President Trump's Executive Order on kidney care

Monday, June 3, 2019

Steps towards reimbursing kidney donors--update from Frank McCormick

Thursday, December 27, 2018

Compensate living donors for lost wages and other expenses?

Removing disincentives to kidney donation, by McCormick et al. in J.Am.Soc.Nephrology

Here's the latest paper in an illuminating series on the costs and consequences of kidney donation and transplantation:

McCormick F, Held PJ, Chertow G, Peters T, and Roberts J.  Removing Disincentives to Kidney Donation: A Quantitative Analysis.  J Am Soc Nephrol 30: ccc–ccc, 2019. doi: https://doi.org/10.1681/ASN.2019030242 is:

https://jasn.asnjournals.org/content/jnephrol/early/2019/07/23/ASN.2019030242.full.pdf

I'm fortunate to be on McCormick's distribution list for email updates on matters related to kidney transplantation, and here's how he introduced and summarized this paper (the table of cost estimates is at the very bottom):

"Friends,

About two years ago, Economics Nobel Laureate Alvin Roth observed that since no-one in the transplant community seemed to be opposed to removing disincentives to kidney donation, the community should unite behind accomplishing that goal.  Our just-published article -- “Removing Disincentives to Kidney Donation: A Quantitative Analysis” -- lays out the consequences of pursuing that consensus objective.  It identifies seven disincentives facing living kidney donors and a single disincentive facing the families of deceased donors. 

The seven disincentives to living donors are listed in column 1 of the table below.  Columns 2 - 5 show estimates of the magnitudes of some of these disincentives made by earlier researchers.  Column 6 indicates our own best estimates of all of the disincentives, and Column 7 specifies the government actions needed to remove these disincentives without violating the National Organ Transplant Act.

Note that the disincentives to living donors total almost $38,000, which is much larger than generally assumed.  This is a substantial deterrent to kidney donation by living donors and goes a long way toward explaining why, even though about 125,400 patients were diagnosed with kidney failure in the U.S. in 2017, most of whom could have benefited from a kidney transplant, only 5,811 patients (4.6%) received a kidney from a living donor.

It follows that if the government could remove all of these disincentives by compensating donors, it could substantially boost kidney donations.  We estimate total donations from both living and deceased donors would increase by about 12,500 per year (63%).  That would cut the waiting list for transplant kidneys (currently numbering about 93,000 patients) in half in about four years.

We estimate removing all the disincentives would require an initial government outlay of only about $0.5 billion per year.  But this investment would quickly be recovered because (a) the long-run cost of transplantation is much less than for dialysis and (b) the government pays most of the costs of both.  So taxpayers would wind up saving a net $1.3 billion each year.  Much more importantly, society would enjoy a net welfare gain of about $14 billion per year, reflecting the great value of the additional donated kidneys to recipients and the savings from these recipients no longer needing expensive dialysis therapy. 

The timing of this article is fortuitous because there is currently great interest in Washington in proposals to remove disincentives to organ donation.  Indeed, on July 10, President Trump issued an executive order stating: “Within 90 days of the date of this order, the Secretary [of the Department of Health and Human Services] shall propose a regulation to remove financial barriers to living organ donation.”

               

Frank

The URL for the just published article: McCormick F, Held PJ, Chertow G, Peters T, and Roberts J.  Removing Disincentives to Kidney Donation: A Quantitative Analysis.  J Am Soc Nephrol 30: ccc–ccc, 2019. doi: https://doi.org/10.1681/ASN.2019030242 is:

https://jasn.asnjournals.org/content/jnephrol/early/2019/07/23/ASN.2019030242.full.pdf

This is the fourth in a series of articles aimed at reducing the kidney shortage and thereby saving tens of thousands of lives each year.  The previous three were:

1.             Held PJ, McCormick F, Ojo A, Roberts JP.  A cost-benefit analysis of government compensation of kidney donors.  Am J Transplant 16: 877–885, 2016.         

This article laid out in great detail (13 Supplements) all of the costs and benefits of compensating kidney donors, showing it would confer a net benefit on society of about $46 billion per year and would save taxpayers about $12 billion per year.

https://onlinelibrary.wiley.com/doi/full/10.1111/ajt.13490

2.       Held PJ, McCormick F, Chertow GM, Peters TG, Roberts JP.  Would government compensation of living kidney donors exploit the poor? An empirical analysis.  PLOS ONE, November 28, 2018. 

This article presented evidence that the poor would not be exploited by government compensation of kidney donors.  Indeed, the aggregate net benefit to the poor would increase to $12 billion per year from only $1 billion per year currently.

https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0205655&type=printable

 

 

3.       McCormick F, Held PJ, Chertow GM.  The Terrible Toll of the Kidney Shortage.   J Am Soc Nephrol 29: 2775–2776, 2018.

This editorial argued that the shortage of transplant kidneys is causing the needless premature deaths of about 43,000 Americans each year (118 per day), the same death toll as from 85 fully loaded 747s crashing each year.  This is a much larger number than had previously been assumed. 

 https://jasn.asnjournals.org/content/jnephrol/29/12/2775.full.pdf

Table 1 Disincentives to Kidney Donation Facing Living Donors
(1) Disincentive		Estimated Magnitudes of Disincentives (Adjusted to U.S. prices and standard of living in 2017)					(7) Proposed Government Action To Remove  the Disincentive
		(2) Gaston          et al.      (2006)	(3) Becker – Elías  (2007)	(4) Rodrigue  et al.    (2016)	(5) Przech  et al.    (2018)	(6) McCormick – Held  et al.  (this study)
1	Travel to, and lodging near, a transplant center	$4,313	--	$1,945	$1,653	$3,122	Expand current NLDAC program to include donors of all income levels
2	Loss of income while recovering from surgery		$3,631	$5,118	$4,368	$5,118	Expand current NLDAC pilot program to include donors of all income levels, providing donors with a tax credit of $5,000
3	Cost of home/ dependent care	--	--	--	$5,592	$5,592	Include cost of home/ dependent care in NLDAC program, providing donors with a tax credit of $6,000
4	Risk of dying during kidney removal	$2,951	$6,723	--	--	$1,860	Provide donors with a $5 million short-term life insurance policy
5	Pain and discomfort of kidney removal	$6,414	--	--	--	$6,414	Provide donors with a tax credit of $6,500
6	Decrease in the long-term quality of life	$23,250	$10,085	--	--	$7,910	Provide donors with an insurance policy covering death, disability, and long-term health problems due to donation
7	Concern that a relative or close friend may need a kidney in the future	--	--	--	--	$7,728	Promise to provide a kidney in the future for a specific person in exchange for a donation now
Total		$36,928	$20,439	--	--	$37,745

President Trump's Executive Order on kidney care

On July 10, while I was in China, President Trump issued an executive order touching on all aspects of care for kidney patients, including dialysis and transplantation from both deceased and living donors.

Here's the text of that executive order:
Executive Order on Advancing American Kidney Health
 Issued on: July 10, 2019

Because I anticipated being potentially incommunicado when the executive order was announced, I had filed an op-ed article (giving my proxy to my coauthor Greg Segal for any necessary last-minute edits) to be published on CNN's web site, applauding the order:
The Trump administration's organ donation efforts will save lives
By Alvin E. Roth and Greg Segal
Updated 1:20 PM ET, Wed July 10, 2019

As it happens, a reporter for PBS news hour reached me by phone in China, and so I got to chime in in person:
Trump’s plan to combat kidney disease aims to save money and lives. Can it?
Health Jul 10, 2019 4:39 PM EDT


The part of the executive order that touches most closely on my work on kidney exchange is Section 8:

"Sec. 8.  Supporting Living Organ Donors.  Within 90 days of the date of this order, the Secretary 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."

Regarding deceased donor transplants, Section 7 says

"Sec. 7.  Increasing Utilization of Available Organs.  (a)  Within 90 days of the date of this order, the Secretary shall propose a regulation to enhance the procurement and utilization of organs available through deceased donation by revising Organ Procurement Organization (OPO) rules and evaluation metrics to establish more transparent, reliable, and enforceable objective metrics for evaluating an OPO’s performance.

(b)  Within 180 days of the date of this order, the Secretary shall streamline and expedite the process of kidney matching and delivery to reduce the discard rate.  Removing process inefficiencies in matching and delivery that result in delayed acceptance by transplant centers will reduce the detrimental effects on organ quality of prolonged time with reduced or cut-off blood supply."

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Here is some of the news coverage:

Trump signs executive order revamping kidney care, organ transplantation By Lenny Bernstein July 10 (Washington Post);
Trump signs executive order to transform kidney care, increase transplants 
By Jen Christensen and Betsy Klein, CNN Updated 4:21 PM ET, Wed July 10, 2019

This executive order is well worth supporting, and it will need support to achieve the goals it outlines.  The Secretary of Health and Human Services has been directed to do things in fairly broad terms, and we'll have to watch carefully to see the results, which will be interpreted, contested, and implemented through multiple political/regulatory processess

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Regarding removing financial disincentives for kidney (and liver) donors, I'm on the advisory board of the federally funded National Living Donor Assistance Center (NLDAC), which has been able, under very tight constraints, to reimburse some donors for some travel expenses (see related posts here).  A minimalist interpretation/implementation of the Executive Order would be to relax some of the constraints on whose expenses and which expenses can be reimbursed, and to increase NLDAC's budget accordingly.  A more expansive interpretation would be to remove some of those constraints so that no donor would have to pay to rescue someone with kidney failure by donating a kidney.

Steps towards reimbursing kidney donors--update from Frank McCormick

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

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

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

Title: Removing Financial Disincentives to Living Organ Donation 

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


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

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

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

Compensate living donors for lost wages and other expenses?

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

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

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

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

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

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

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

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

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

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

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