Presidential DocumentExecutive Order 138792019-15159
Advancing American Kidney Health
Primary source
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Published
July 15, 2019
Signed
July 10, 2019
Issuing agencies
Executive Office of the President
Full Text
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<title>Federal Register, Volume 84 Issue 135 (Monday, July 15, 2019)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2019-15159]
[[Page 33815]]
Vol. 84
Monday,
No. 135
July 15, 2019
Part II
The President
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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
to:
(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
regulations.
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
disease.
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
patients.
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
Nephrology.
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
appropriations.
[[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.
<GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT>
(Presidential Sig.)
THE WHITE HOUSE,
July 10, 2019.
[FR Doc. 2019-15159
Filed 7-12-19; 11:15 am]
Billing code 3295-F9-P
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