[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 [www.gpo.gov]
[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
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  Federal Register / Vol. 84 , No. 135 / Monday, July 15, 2019 / 
Presidential Documents  

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 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.
                
                
                    (Presidential Sig.)

                THE WHITE HOUSE,

                    July 10, 2019.

[FR Doc. 2019-15159
Filed 7-12-19; 11:15 am]
Billing code 3295-F9-P