On July 10, 2019, President Trump issued an Executive Order on Advancing American Kidney Health aimed at reducing the number of patients developing kidney failure, having fewer Americans receiving dialysis in dialysis centers, and making more kidneys available for transplant (the Order). The Order calls on the Secretary of HHS to, among other things, develop a payment model designed to identify at-risk patients earlier in disease development and increase home dialysis and kidney transplants. The Order also tasks the Secretary to reform regulations regarding the evaluation metrics for Organ Procurement Organizations (OPOs). These steps, and others, are set to roll out as early as 30 days from the Order.

The Order’s policy initiatives are three-fold. The first goal is to “prevent kidney failure whenever possible through better diagnosis, treatment, and incentives for preventive care.” The second is to “increase patient choice through affordable alternative treatments for end stage renal disease (ESRD) by encouraging higher value care, educating patients on treatment alternatives, and encouraging the development of artificial kidneys.” The third initiative is to “increase access to kidney transplants by modernizing the organ recovery and transplantation systems and updating outmoded and counterproductive regulations.” A press release by HHS added specifics to the President’s goals:

• Reducing the number of Americans developing end-stage renal disease by 25 percent by 2030;
• Having 80 percent of new ESRD patients in 2025 either receiving dialysis at home or receiving a transplant; and
• Doubling the number of kidneys available for transplant by 2030.

HHS is tasked with developing new payment models and initiatives to implement the Order. Specifically, the Secretary is called upon to launch several initiatives to promote kidney disease awareness and support research regarding prevention and treatment. The Secretary shall also develop a payment model to test innovations in compensation for providers of kidney care services based on kidney patient cost and quality outcomes, with a focus on delaying or preventing the onset of kidney failure, preventing unnecessary hospitalizations, increasing the rate of transplants and creating incentives to provide care for Medicare beneficiaries who have advanced stages of kidney disease but who are not yet on dialysis. The Secretary shall also select a payment model incentivizing greater use of home dialysis and kidney transplants for Medicare beneficiaries on dialysis.

According to HHS’s press release, the Center for Medicare & Medicaid Innovation (CMMI) has responded to the Order by releasing a set of four optional payment models, expected to enroll more than 200,000 Medicare patients in arrangements that give providers new incentives for preventing kidney disease and managing kidney patients’ health in a more comprehensive and person-centered way. To provide more options for people with kidney failure, CMMI also announced a required payment model, known as ESRD Treatment Choices, which will enroll all dialysis providers in approximately half of the country and provide new incentives to encourage dialysis in the home.

The Order also forecasts regulatory changes for OPOs—the organizations responsible for working with hospitals to help place donor organs for transplant. The Order requires the Secretary to issue regulations and evaluation metrics to establish more transparent, reliable, and enforceable objective metrics for evaluating an OPO’s performance. Additionally, the Secretary is charged to streamline and expedite the process of kidney matching and delivery to reduce the discard rate by removing process inefficiencies in matching and delivery that result in delayed acceptance by transplant centers.

Additionally, the Order calls for the Secretary to consider requests for premarket approval of wearable or implantable artificial kidneys. This step is designed to encourage development and cooperation between developers and FDA, as well as produce a strategy to encourage innovation in new therapies through the Kidney Innovation Accelerator (KidneyX), a public-private partnership between HHS and the American Society of Nephrology.

Finally, the Secretary shall propose a regulation to remove financial barriers to living organ donation by expanding the definition of allowable costs that can be reimbursed under the current program. Proposals would include raising the limit on the income of donors eligible for reimbursement under the program, allowing reimbursement for lost-wage expenses, and providing for reimbursement of child-care and elder-care expenses.