President Trump on Wednesday issued an executive order that calls on HHS to overhaul the kidney care and donation allocation process, and HHS shortly after unveiled new payment models for Medicare providers who manage patients with kidney disease and end-stage renal disease (ESRD).

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About the executive order

Trump in the executive order noted that more than 726,000 Americans have ESRD and about 37 million have chronic kidney disease, which was the ninth-leading cause of death in the United States in 2017.

"The state of care for patients with chronic kidney disease and 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," the executive order states. 

To improve the system of care for those patients, Trump's executive order calls on HHS to develop policies that address three broad goals:

• Improving the organ donation process for living and deceased donors;
• Raising awareness about chronic kidney disease and ESRD; and
• Improving the quality of care through innovative payment models and technologies.

HHS in an accompanying report outlined specific metrics the department aims to meet:

• In 2025, ensure 80% of new ESRD patients receive either home dialysis or a transplant;
• By 2030, reduce the number of Americans developing ESRD by 25%; and
• By 2023, double the number of kidneys available for transplant.

How Trump wants to improve the organ donation process

Trump in the order directed HHS within 90 days to propose a regulation to revise the Organ Procurement Organization (OPO) rules and evaluation metrics to improve kidney procurement and use, and within 180 days to overhaul the kidney matching and delivery process to reduce inefficiencies.

OPOs have come under fire in recent years for underusing deceased donor organs. According to Vox, one report estimated as many as 28,000 organs go unused, while other estimates say the number of unused organs could exceed 75,000.

In addition, Trump directed HHS to propose a regulation to expand edibility for living donor financial assistance. As Vox reports, living organ donors typically do not pay for their medical procedure, but they could be required to pay for other expenses, such as travel and child care, and they could suffer lost wages during their recovery. Currently, low-income donors can be reimbursed for travel expenses, but Trump's order calls on HHS to expand eligibility to include those with higher incomes and to expand the types of expenses donors can be reimbursed for.

How Trump wants to raise awareness

Trumps executive order also calls on HHS to launch an initiative within 120 days that aims to raise awareness about kidney disease and ESRD in the United States.

Specifically, Trump's order directs HHS to develop proposals to:

• Support research on kidney disease, including finding alternative treatment methods;
• Improve the kidney transplantation system; and
• Share information with patients and providers to enhance awareness of the causes and consequences of kidney disease.

In addition, the order challenges HHS within 120 days to develop a strategy to encourage innovative new therapies, and for FDA to begin accepting premarket approval applications for artificial kidneys.

How Trump wants to improve the quality of care—and how HHS plans to get it done

Trump's order also directed HHS to develop alternative payment models to test new ways of compensating providers for kidney care services. The goal is to encourage providers to identify and treat at-risk populations while the disease is in the early stages, as well as to identify new payment models to encourage in-home dialysis and other treatment options.

Shortly after Trump's announcement, HHS unveiled five new payment models related to ESRD and kidney care, including a new proposed mandatory payment model.

Under the proposed mandatory ESRD Treatment Choice model, CMS would assess participating providers based on their rates of kidney and kidney-pancreas transplant and home dialysis. The model would include ESRD facilities, nephrologists and other providers who manage care for ESRD beneficiaries. CMS said it opted for a mandatory model to achieve a wider range of ESRD facilities and clinicians. The agency said it plans to randomly select participants from across the country that manage about 50% of the U.S. adult ESRD beneficiaries.

Participating providers would receive a Medicare payment boost or penalty based on their rates of kidney and kidney-pancreas transplant and home dialysis. The program would launch in 2020, and the financial adjustments would take effect in 2021 and vary annually through June 30, 2026 based on the previous year's performance.

To encourage participating ERSD facilities and clinicians to give beneficiaries access to in-home dialysis, CMS under the model also would positively adjust Medicare payments for the first three years for home dialysis and dialysis-related services. CMS will accept public comment on the proposed model for 60 days.

The agency also announced new voluntary payment models to test alternative Medicare payment options that aim to improve care quality for beneficiaries with kidney disease.

The Kidney Care First (KCF) model, which is open only to nephrology practices, will tie payments to beneficiaries' health outcomes, the health services used, and quality measures. Participating providers under this model will receive a payment boost over a three-year period for every beneficiary with advanced chronic kidney disease or ESRD who receives a transplant. In order for providers to receive the full bonus, the transplant must be successful for the full three years.

The Comprehensive Kidney Care Contracting (CKCC) model consists of three tracks:

• CKCC Graduated, which begins as a one-sided risk model and slowly phases in additional risks and rewards;
• CKCC Professional, which gives participating clinicians the option to earn 50% of shared savings and be on the hook for 50% of shared losses based on the total cost of care for Part A and B services; and
• Global Models, which requires participating clinicians to take on 100% of the financial risk based on the total cost of care for Part A and B services.

Reaction

DaVita CEO Javier Rodriguez said the company is encouraged by the administration's proposals. "In partnership with nephrologists, we are best positioned to deliver in the home dialysis space, as the largest provider of home dialysis in the United States." He added, "We're accelerating home growth with our investments in technologies, such as home remote monitoring and a telehealth platform, to make it easier for patients to treat at home."

Kidney Care Partners expressed an eagerness to work with the Trump administration on the future proposals. "KCP is committed to respect the desires and interest of patients in selecting the modality they believe will work best for them, as well as working with the Trump administration to develop an appropriate path that will move us closer to the aspirational targets the President has referenced today," the group said

In a statement, the Association of Organ Procurement Organizations said its members "support the goal of enhanced performance metrics that improve the ability to recover and deliver organs to those who need them." The organization also said that changes to expand the pool of acceptable organ donors would increase transplantation because about "20% of available donor kidneys were discarded rather than being transplanted" in 2018.

Jennifer Erickson, a former White House staffer who worked on organ donation under former President Barack Obama's administration, said of the new organ donation proposals. "This is a chance for HHS to ensure that OPOs are honoring organ donor wishes." She added, "This is life or death for tens of thousands of people" (Matthews, Vox, 7/10; Simmons-Duffin, "Shots," NPR, 7/10; Stein, Inside Health Policy, 7/10 [subscription required]; Bernstein, Washington Post, 7/10; Bernstein/Kindy, Washington Post, 7/10; CMS fact sheet, 7/10).