The American Society of Nephrology (ASN) Department of Policy and Public Affairs team has received numerous questions from interested members and from the broader kidney community on the recent Executive Order on Advancing American Kidney Health and the accompanying Department of Health and Human Services report highlighting specific initiatives. In order to engage with our members, we will be running a series in Kidney News Online that addresses these questions. This is the second piece in that series.

The Department of Health and Human Services (HHS) report on Advancing American Kidney Health initiative (AAKHi) aims to “double the number of kidneys available for transplant by 2030”. This article covers some questions related to this audacious goal.

If you have additional questions that you would like to see answered in the next article please contact the ASN Department of Policy and Public Affairs team at policy@asn-online.org .

If you missed it, please see the first installment of this series for additional information.
 

1. How will the AAKHi increase the utilization and availability of kidneys for transplant?

In order to double the number of kidneys available for transplant by 2030, the Administration is looking to increase the utilization of available organs from both deceased and living donors in multiple ways including, but not limited to:

• The Collaborative Innovation and Improvement Network project supported by the Health Resources and Services Administration (HRSA) looked at increasing transplantation by focusing on increasing the utilization of kidneys deemed to me moderate to higher risk. Among the first cohort of participating transplant programs, the initial results suggest the program has resulted in increased utilization of kidneys.
• The Centers for Medicare and Medicaid Services (CMS) added a transplant waitlist measure to ESRD Quality Incentive Program linking a portion of payment directly to dialysis facilities’ performance on the measure.
• HHS is organizing a workshop to discuss considerations related to the Use of Hepatitis C virus (HCV) positive donor organs in recipients who do not have HCV. With the advent of direct acting anti-viral therapy, use HCV+ donor organs in HCV uninfected recipients have been found to be safe and effective when proactively using the therapy. The workshop will review potential changes in the standard of clinical care in transplantation.
• The proposed ESRD Treatment Choices (ETC) Model announced that in conjunction with the model CMS will operate a voluntary learning system focused on increasing the availability of deceased donor kidneys for transplantation.  The learning center would support and work with ETC participants and other stakeholders required for successful kidney transplantation, such as transplant centers, organ procurement organizations (OPOs), and large donor hospitals.

We would encourage you to read the entire Advancing American Kidney Health report for more examples.
 

2. How are transplant centers incorporated into the AAKHi?

The CMS proposed End-Stage Renal Disease Treatment Choices model encourages relationships between nephrologists and transplant centers. We expect that this will be further refined once the four voluntary models are publicly released. ASN will review and provide recommendations for refinement on the voluntary models once they become available.

Also, in order to increase the utilization of available organs, the Order directs HHS to revise, within 120 days, Organ Procurement Organization (OPO) rules and evaluation metrics to establish more transparent, reliable, and enforceable objective metrics for evaluating an OPO’s performance. HHS is also required to streamline and expedite the process of kidney matching and delivery to reduce the discard rate within 180 days. Th e initiative plans to boost transplantation using several levers, in addition to OPO metrics, such as more support for living organ donors.

The White House had already announced in its spring agenda for rulemaking that HHS would be issuing a proposed rule to provide financial assistance for living organ donors. ASN, the American Association of Kidney Patients (AAKP), and others in the kidney community have been advocating for more support for living donors, including coverage of lost wages, with HHS and Congress for many years. The Executive Order specifically directs HHS that new regulation in this area “should expand the definition of allowable costs that can be reimbursed under the Reimbursement of Travel and Subsistence Expenses Incurred Toward Living Organ Donation program, raise the limit on the income of donors eligible for reimbursement under the program, allow reimbursement for lost-wage expenses, and provide for reimbursement of child-care and elder-care expenses.”
 

3. How does the AAKHi address xenotransplantation?

Xenotransplantation is an exciting and emerging field and could increase the potential supply of donor kidneys. While xenotransplantation is not explicitly mentioned the HHS report, we expect xenotransplantation as well as other ideas on artificial kidneys to be submitted to KidneyX Redesign Dialysis Phase II competition (ongoing) and Phase III (launching in 2020).
 

4. Are people that qualify going to be paid to donate a kidney?

Recognizing that many financial disincentives to donation persist that may discourage an individual from donating a kidney, HHS has looked into ways to increase the number of living donors by removing disincentives.

HRSA is planning to expand the Reimbursement of Travel and Subsistence Expenses toward Living Organ Donation program by increasing the income threshold. Travel expenses are the primary cause of reimbursement now, but a HRSA three-year demonstration project is piloting reimbursement of up to $5,000 in lost wages related to donor evaluation and surgical procedures, regardless of the donor’s income.

No donors will be reimbursed for the kidney themselves.

5. Does AAKHi encourage drug development that would enable transplantation or only devices, artificial kidneys, etc.?

The AAKHi specifically "supports efforts to develop and bring to market novel treatments such as wearable, implantable, and/or biohybrid artificial kidneys as well as other biological and drug-based alternatives to current dialysis treatments".

The National Institutes of Health’s Kidney Precision Medicine Project aims to lead to new biomarkers, disease subgroups, molecular targets, and most importantly the development of new drugs to treat and possibly forestall kidney disease.

CMS is also considering ways to encourage ESRD facilities to furnish new and innovative drugs and biological products for the treatment of ESRD. The Transitional Drug Add-on Payment Adjustment (TDAPA) is an add-on payment adjustment under the ESRD PPS intended to facilitate this goal for Medicare beneficiaries. This is done by encouraging ESRD facilities to furnish certain qualifying new renal dialysis drugs and biological products by allowing additional payment for them while utilization data is collected.

We would encourage you to read the entire Advancing American Kidney Health report for more examples.