Trump’s Executive Order on Advancing American Kidney Health: What It Means for Patients and Providers

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On Wednesday, July 10, 2019, President Trump signed the “Executive Order on Advancing American Kidney Health,” in order to revamp kidney disease treatments and organ donation systems in the United States. Because tens of thousands of people die annually in relation to kidney disease or failure, and because dialysis is both expensive and time-intensive, the executive order may potentially save thousands of lives and billions of dollars every year.

The executive order proclaims that it is a 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 end stage renal disease (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.

In furtherance of this policy, the executive order directs that the Secretary of Health and Human Services (HHS) must:

  • launch an awareness initiative on kidney and related diseases;
  • select an innovative payment model to identify and treat at-risk populations earlier in disease development;
  • select a payment model with incentives to increase home dialysis and kidney transplants;
  • encourage the development of an artificial kidney by announcing that the HHS will consider requests for premarket approval of artificial kidneys and by encouraging innovation through the Kidney Innovation Accelerator (KidneyX);
  • increase the utilization of available organs by proposing regulations to enhance the procurement and utilization of organs from deceased donors and by streamlining the process of kidney matching and delivery to reduce the discard rate and remove inefficiencies; and
  • support living organ donors by proposing regulations to remove financial barriers to living organ donation.

What This Means for Patients and Providers

Patients will have better access to information regarding kidney disease prevention, detection, diagnosis and treatment, and will also have more affordable treatment options for end-stage renal disease, including in-home dialysis and early transplant options.

The primary treatment for kidney disease is currently center-based dialysis. Because the executive order aims to dramatically shift kidney care away from clinics towards home-based care, providers will need to shift their business models accordingly. Davita Kidney Care and Fresenius Medical Care, who combined currently control more than 80% of the kidney dialysis market, have already issued press releases pledging to expand their home dialysis capacity.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Attorney Advertising.

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