Saturday, September 21, 2019

The Advancing American Kidney Health Executive Order: An Opportunity to Enhance Organ Donation | Nephrology | JAMA | JAMA Network

From. JAMA, September 20, 2019
Elizabeth Thomas, DO1; Jennifer Milton, RN, MBA1; Francisco G. Cigarroa, MD

The effect of kidney disease on the nation’s health is significant and expensive. Kidney disease affects more than 30 million individuals in the United States and is recognized as the 10th leading cause of premature mortality. 2 Patients receiving dialysis who are younger than 80 years are expected to live less than one-third as long as their counterparts without ESKD.2 The estimated cost of Medicare spending for beneficiaries with chronic kidney disease and ESKD exceeded $114 billion in 2016.

Prevention, treatment, and research are essential strategies in the management of patients with kidney disease and are highlighted in the 3 goals of the executive order. The aim of the first and second goals is to reduce the burden of renal disease over time, whereas the third goal will provide the most immediate benefit for patients with ESKD. This goal focuses on deceased donors and living donors for kidney transplantation.



In the United States, the waiting list for a kidney is about 100,000 people.  Alternatives for ESRD are renal dialysis, cadaver donors, and living donors.  The success and survival rates are high in both cases, with rates approaching 85-95%. A living kidney donor yields the highest success and duration.

Attracting suitable donors include organ donation promotion through a choice listed on driver license cards, public service announcements, and joining the National Kidney Registry or register at your local hospital, medical university or by calling

Click here to see if you are qualified to donate.

Considering Kidney Donation?  Legal, Financial and other concerns for the donor

Kidney donation is an amazing gift but is also major surgery involving:

Medical tests that will require at least one full day at the hospital.
1 – 3 days in the hospital after surgery.
Typically 2 – 4 weeks off work for recovery.

There are means to offset the loss of income for donors who have an income of less than 62,000 per annum.

The most successful kidney donors are immediate family members related by blood, such as brothers, sisters, cousins or close aunts and uncles. Gender has no determining effect.

Efforts to improve the live kidney donor program should include:

The Advancing American Kidney Health Executive Order serves as a framework for furhter improvement in the Live Kidney Donor programs.


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Viewpoint
September 20, 2019
The Advancing American Kidney Health Executive Order
An Opportunity to Enhance Organ Donation
Elizabeth Thomas, DO1; Jennifer Milton, RN, MBA1; Francisco G. Cigarroa, MD1
Author Affiliations Article Information
JAMA. Published online September 20, 2019. doi:10.1001/jama.2019.14500
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Audio Interview (23:35)
The Advancing American Kidney Health Executive Order
On July 10, 2019, President Trump signed an executive order to launch “Advancing American Kidney Health,” an outline of policy priorities centered on advancing 3 main goals: (1) preventing kidney failure whenever possible through better diagnosis, treatment, and incentives for preventive care; (2) increasing patient choice through affordable alternative treatments for end-stage kidney disease (ESKD) by encouraging higher-value care, educating patients on treatment alternatives, and encouraging the development of artificial kidneys; and (3) increasing access to kidney transplantation by modernizing the organ recovery and transplantation systems and updating outmoded and counterproductive regulations.1

The effect of kidney disease on the nation’s health is significant and expensive. Kidney disease affects more than 30 million individuals in the United States and is recognized as the 10th leading cause of premature mortality.2 Patients receiving dialysis who are younger than 80 years are expected to live less than one-third as long as their counterparts without ESKD.2 The estimated cost of Medicare spending for beneficiaries with chronic kidney disease and ESKD exceeded $114 billion in 2016.2

Prevention, treatment, and research are essential strategies in the management of patients with kidney disease and are highlighted in the 3 goals of the executive order. The aim of the first and second goals is to reduce the burden of renal disease over time, whereas the third goal will provide the most immediate benefit for patients with ESKD. This goal focuses on deceased donors and living donors for kidney transplantation.

Regarding deceased donation, the executive order introduces strategies to improve the use of organs from deceased donors, but more can be done. For example, increasing the number of registered donors is critical to augmenting organ donation. Donor registries allow individuals to register their legally binding decision to donate rather than leaving the decision to their surrogate decision-maker. Data suggest that the most effective donation authorization strategy for the United States is to build on the current opt-in system and to increase the number of registered donors from 54% to more than 75%, considering that the majority of residents indicate they would donate their organs.3 This percentage increase would increase available organs for donation and could save thousands of lives. Moreover, educational campaigns, such as the establishment of RegisterMe.org and registration via the iPhone Health app, could substantially increase the number of registered donors. In addition, hospitals must ensure donor registrations are honored through staff and physician education as well as quality reviews and process improvements focused on root causes of any failure to proceed with procurement of organs from a medically suitable and registered organ donor.

Another important endeavor with the capacity to increase potential transplants involves how to better allocate kidneys from individuals with unique risks such as those (1) with a high kidney donor profile index (KDPI), (2) at increased risk for transmitting HIV, hepatitis B virus, or hepatitis C virus (HCV) (risk designated by the US Public Health Service), and (3) from donors infected with HCV. The KDPI is a numerical measure that combines 10 donor factors to summarize into a single number the quality of deceased donor kidneys relative to other recovered kidneys. It is a useful index, but should not be used in isolation because transplantation outcomes are dependent on variables from both the donor and recipient.

To decrease the number of organs not being used because of a high KDPI, transplantation programs would benefit from access to high-quality biopsies with prompt interpretations by experienced pathologists and ex-vivo perfusion to better characterize the quality of the kidneys and better predict outcome. For increased risk donors as defined by the Public Health Service, the standard use of nucleic acid testing minimizes the risk of unknowingly exposing a recipient to infections such as HCV and HIV. The estimated window period of risk (the time between acquisition of infection and serological detectability) with nucleic acid testing for HCV ranged from 0.027 to 32.4 per 10 000 donors and the window period of risk for HIV infection ranged from 0.04 to 4.9 per 10 000 donors based on the types of at-risk behaviors of the donor.4,5

Known HCV-positive donor organs can be given to HCV-negative recipients with informed consent, given the availability of antiviral therapies that achieve undetectable levels of HCV in 95% to 100% of patients with HCV infection after 12 to 24 weeks of treatment. Physicians and patients should understand the benefits of good organ function far outweigh the risks of infection in the majority of cases, given the effectiveness of nucleic acid testing and antiviral therapies. Although the Centers for Medicare & Medicaid Services and the United Network for Organ Sharing encourage transplantation centers to expand the use of these organs within the context of considering the benefits and risks to the patient, increasing the reimbursement by payers for using these organs would most likely incentivize their use and offset the higher costs of patient care and monitoring required after transplantation.

Living donors offer the most promising option for increasing the number of successful kidney transplants. The 5-year survival rate for patients receiving a kidney graft from a living donor is 85% on average vs 75% from a deceased donor, and the 10-year graft survival rate is 65% vs 48%, respectively.6 A living donor graft is less likely to develop delayed graft function that affects the overall quality and longevity of the transplanted kidney.6 Recipients of living kidney donors also do not have to wait for their transplant, whereas those without a living donor wait 5 years on average for their transplant. Similarly, recipients of living donor kidneys can avoid starting dialysis in most cases, will not accumulate the morbidities that accompany kidney disease or dialysis over time, maintain a higher quality of life, all of which reduce the costs to the health care system and Medicare spending. Estimated health care system costs are more than $89 000 per patient per year once dialysis has begun.7 By maximizing living donor transplants, more deceased donor organs will be available to patients who do not have a living donor.

Why are more living kidney donor transplants and other living donor organ transplants (such as liver) not occurring? The primary reasons are (1) recipient’s and donor’s incomplete knowledge of the adverse effects of kidney disease or another end-stage organ disease; (2) inadequate education regarding the safety and recovery of the surgical procedure; and (3) the concern for incurring debt and potential for long-term health risks.

Public health campaigns to communicate the importance and safety of living kidney donation are needed. Based on United Network for Organ Sharing requirements and policies, the living donor evaluation is extremely thorough and continually prioritizes the safety and well-being of the donor, both at the time of donation and for any estimated future risks. The perioperative mortality for donor nephrectomy is 3.1 per 10 000 donors.8 The estimated cumulative incidence of ESKD at 20 years after a donation is 50.9 per 10 000 donors.9 The absolute risk of developing ESKD is slightly higher among donors who are younger at donation (38.0 vs 41.0 years), black, male, obese (body mass index >30), is a first-degree relative of the transplant recipient, and who are less likely to live in a wealthy neighborhood, but this risk is still at less than 1%.10 Long-term survival among donors and healthy comparison patients is similar.8

The expansions in charitable assistance described in the executive order could serve to reduce the burden of lost wages, travel expenses, and other costs living donors encounter. It is imperative that federal donor-directed policies are put into place such that qualified and willing living donors are not disincentivized based on potential financial hardships related to donation, concerns about loss of employment, and apprehensions about increased health insurance premiums or loss of coverage after donation. These disincentives are not hypothetical but real. In some cases, inadequate post-donation coverage offered by the recipient’s insurance and limited donor insurance plans has led to the loss of otherwise qualified donors to provide life-saving grafts to their intended recipients. Although insurers may have effective coverage for preoperative evaluation and donation, they may have limited or no coverage for routine care required after donation, including federally mandated follow-up, and limited or no coverage for complications related to organ donation. Routine post-donation care is usually inexpensive, and complications are rare, so the lack of coverage is illogical and unacceptable.

The need to better support living donors is important not only to reduce the burden of end-stage organ failure but also from the obligation of the community to support those generous individuals willing to be donors. Their gift is a sacrifice that deserves gratitude. There should be federal protection against loss of employment and consistency among all private payer insurance companies to cover any donor-related health care costs to a living donor for 1 year after organ donation. Options under Medicare should exist to reimburse unpaid medical expenses after donation not covered by private payers. Private insurance or federal funding should be provided to donors for all reasonable travel and accommodations related to donation. Federal mandates should protect living donors from having the status of a preexisting condition simply due to their donor status. This kind of support would allow many willing donors to realize their desire to donate and it could provide life-saving organs to recipients in need.


This Viewpoint uses provisions in President Trump’s 2019 American Kidney Health Executive order calling for an increase in access to kidney transplantation to discuss strategies to increase deceased and living donor pools, improve the allocation of organs from higher-risk donors, and support the...





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https://jamanetwork.com/journals/jama/fullarticle/2752027?guestAccessKey=214cd8ce-f070-454d-9b0b-22f23d946e74&utm_source=silverchair&utm_medium=email&utm_campaign=article_alert-jama&utm_content=olf&utm_term=092019

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