Advancing American Kidney Health

Federal Register, Volume 84 Issue 135 (Monday, July 15, 2019)
[Federal Register Volume 84, Number 135 (Monday, July 15, 2019)]
[Presidential Documents]
[Pages 33817-33819]
From the Federal Register Online via the Government Publishing Office []
[FR Doc No: 2019-15159]
[[Page 33815]]
Vol. 84
No. 135
July 15, 2019
Part II
The President
Executive Order 13879--Advancing American Kidney Health
                        Presidential Documents
Federal Register / Vol. 84 , No. 135 / Monday, July 15, 2019 /
Presidential Documents
Title 3--
The President
[[Page 33817]]
                Executive Order 13879 of July 10, 2019

Advancing American Kidney Health
                By the authority vested in me as President by the
                Constitution and the laws of the United States of
                America, it is hereby ordered as follows:
                Section 1. Purpose. My Administration is dedicated to
                advancing American kidney health. The state of care for
                patients with chronic kidney disease and end-stage
                renal disease (ESRD) is unacceptable: too many at-risk
                patients progress to late-stage kidney failure; the
                mortality rate is too high; current treatment options
                are expensive and do not produce an acceptable quality
                of life; and there are not enough kidneys donated to
                meet the current demand for transplants.
                Kidney disease was the ninth-leading cause of death in
                the United States in 2017. Approximately 37 million
                Americans have chronic kidney disease and more than
                726,000 have ESRD. More than 100,000 Americans begin
                dialysis each year to treat ESRD. Twenty percent die
                within a year; fifty percent die within 5 years.
                Currently, nearly 100,000 Americans are on the waiting
                list to receive a kidney transplant.
                Sec. 2. Policy. It is the policy of the United States
                    (a) prevent kidney failure whenever possible
                through better diagnosis, treatment, and incentives for
                preventive care;
                    (b) increase patient choice through affordable
                alternative treatments for ESRD by encouraging higher
                value care, educating patients on treatment
                alternatives, and encouraging the development of
                artificial kidneys; and
                    (c) increase access to kidney transplants by
                modernizing the organ recovery and transplantation
                systems and updating outmoded and counterproductive
                Sec. 3. Announcing an Awareness Initiative on Kidney
                and Related Diseases. Within 120 days of the date of
                this order, the Secretary of Health and Human Services
                (Secretary) shall launch an awareness initiative at the
                Department of Health and Human Services (Department) to
                aid the Secretary's efforts to educate patients and
                support programs that promote kidney disease awareness.
                The initiative shall develop proposals for the
                Secretary to support research regarding preventing,
                treating, and slowing progression of kidney disease; to
                improve kidney transplantation; and to share
                information with patients and providers to enhance
                awareness of the causes and consequences of kidney
                Sec. 4. Payment Model to Identify and Treat At-Risk
                Populations Earlier in Disease Development. Within 30
                days of the date of this order, the Secretary shall
                select a payment model to test innovations in
                compensation for providers of kidney care services
                based on kidney patient cost and quality outcomes. The
                model should broaden the range of care and Medicare
                payment options available to potential participants
                with a focus on delaying or preventing the onset of
                kidney failure, preventing unnecessary
                hospitalizations, and increasing the rate of
                transplants. It should aim at achieving these outcomes
                by creating incentives to provide care for Medicare
                beneficiaries who have advanced stages of kidney
                disease but who are not yet on dialysis. The selected
                model shall include options for flexible advance
                payments for nephrologists to better support their
                management and coordination of care for patients with
                kidney disease.
[[Page 33818]]
                Sec. 5. Payment Model to Increase Home Dialysis and
                Kidney Transplants. Within 30 days of the date of this
                order, the Secretary shall select a payment model to
                evaluate the effects of creating payment incentives for
                greater use of home dialysis and kidney transplants for
                Medicare beneficiaries on dialysis. The model should
                adjust payments based on the percentage of a
                participating provider's attributed patients who either
                are on home dialysis or have received a kidney
                transplant and should include a learning system to help
                participants improve performance. Greater rates of home
                dialysis and transplantation will improve quality of
                life and care for patients who require dialysis and may
                eliminate the need for dialysis altogether for many
                Sec. 6. Encouraging the Development of an Artificial
                Kidney. Within 120 days of the date of this order, in
                order to increase breakthrough technologies to provide
                patients suffering from kidney disease with better
                options for care than those that are currently
                available, the Secretary shall:
                    (a) announce that the Department will consider
                requests for premarket approval of wearable or
                implantable artificial kidneys in order to encourage
                their development and to enhance cooperation between
                developers and the Food and Drug Administration; and
                    (b) produce a strategy for encouraging innovation
                in new therapies through the Kidney Innovation
                Accelerator (KidneyX), a public-private partnership
                between the Department and the American Society of
                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.
                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.
                Sec. 9. General Provisions. (a) Nothing in this order
                shall be construed to impair or otherwise affect:
(i) the authority granted by law to an executive department or agency, or
the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget
relating to budgetary, administrative, or legislative proposals.
                    (b) This order shall be implemented consistent with
                applicable law and subject to the availability of
[[Page 33819]]
                    (c) This order is not intended to, and does not,
                create any right or benefit, substantive or procedural,
                enforceable at law or in equity by any party against
                the United States, its departments, agencies, or
                entities, its officers, employees, or agents, or any
                other person.

                    (Presidential Sig.)
                THE WHITE HOUSE,
                    July 10, 2019.
[FR Doc. 2019-15159
Filed 7-12-19; 11:15 am]
Billing code 3295-F9-P