Advancing American Kidney Health

This executive order directs HHS to launch multiple initiatives to transform kidney care in the U.S., including new Medicare payment models to incentivize early treatment and home dialysis, regulatory changes to increase organ donation and transplantation, support for living donors through expanded reimbursement, and accelerated development of artificial kidneys through FDA engagement and the KidneyX public-private partnership.

Federal Register Open PDF 84 FR 33817

Impact dates

Jan 6, 2020
Streamline and expedite kidney matching and delivery to reduce discard rate
Nov 7, 2019
Launch awareness initiative on kidney and related diseases
Nov 7, 2019
Announce FDA premarket approval consideration for artificial kidneys
Nov 7, 2019
Produce KidneyX innovation strategy
Oct 8, 2019
Propose regulation revising OPO rules and evaluation metrics
Oct 8, 2019
Propose regulation removing financial barriers to living organ donation
Aug 9, 2019
Select payment model for early identification/treatment of at-risk kidney patients
Aug 9, 2019
Select payment model to increase home dialysis and kidney transplants

Key directives

Launch awareness initiative on kidney disease within 120 days
Select payment model for early identification and treatment of at-risk kidney patients within 30 days
Select payment model to increase home dialysis and kidney transplants within 30 days
Announce FDA premarket approval consideration for wearable/implantable artificial kidneys within 120 days
Produce KidneyX innovation strategy within 120 days
Propose regulation revising OPO rules and evaluation metrics within 90 days
Streamline and expedite kidney matching and delivery within 180 days
Propose regulation expanding living donor reimbursement within 90 days

Who is ordered

Secretary of Health and Human Services · Department of Health and Human Services

Timeline

Immediate

HHS to select two payment models for kidney care (30 days)
Regulation proposed to revise OPO performance metrics (90 days)
Regulation proposed to remove financial barriers for living donors (90 days)

Near term (90d)

Launch kidney disease awareness initiative (120 days)
Announce FDA premarket approval pathway for artificial kidneys (120 days)
Produce KidneyX innovation strategy (120 days)

Long term

Streamline kidney matching and delivery to reduce organ discard (180 days)
Implementation of payment models and regulatory changes
Potential market entry of wearable/implantable artificial kidneys

Risks & tensions

Payment models require CMS Innovation Center authority and may face legal challenges if structured as mandatory
OPO regulatory changes could face industry resistance from underperforming organizations
Artificial kidney timeline highly uncertain; FDA 'consideration' of requests does not guarantee approval speed
Living donor reimbursement expansion depends on appropriations availability per Section 9(b)
Dual 30-day payment model selections are ambitious and may result in less developed models