President Donald Trump on Wednesday signed an executive order making sweeping changes to kidney disease treatment.
In addition, the CMS launched five new payment models to revamp kidney care. The administration's changes include revising rules to ensure that kidneys reach patients more quickly, moving more patients into home dialysis, encouraging development of artificial kidneys and increasing the number of kidneys available for transplantation.
"This is dramatic, overdue reform," Trump said in remarks made before the signing ceremony.
Four of the new CMS payment models will be voluntary. They will encourage home dialysis and kidney transplants in the hopes that will reduce Medicare costs and improve patients' quality of life.
HHS Secretary Alex Azar had indicated that a shakeup was in the works, noting in remarks to the National Kidney Foundation in March that the agency was planning on shifting from volume to value, with an emphasis on preventing kidney disease; offering more options for treatment, including home dialysis; delivering more organs for transplant; and developing wearable and artificial kidneys to reduce the need for dialysis.
More than 30 million Americans have some stage of kidney disease. In 2016 it was the ninth-leading cause of death in the United States. Medicare spent $113 billion in 2016 to cover people with kidney disease, including end-stage renal disease, representing more than one-fifth of its spending.
Azar had stated that current payment policies were biased toward dialysis performed at centers, and that dialysis companies were disincentivized from helping patient get ready for and find a transplant.
HHS is already experimenting with ways to improve kidney care and reimbursement. The Center for Medicare and Medicaid Innovation launched the Comprehensive ESRD Care Model in 2015, built on accountable care organization experience, to test a new payment and service delivery model to coordinate kidney care. The model, which has 37 participants, runs until Dec. 31, 2020. HHS also announced a change in its allocation policy for liver transplants, but the move was delayed due to litigation.
Congress also has considered kidney treatment reform, with less success. A bill to create a demonstration project to encourage more home dialysis, the Dialysis Patients Demonstration Act, stalled in the last Congress. A different bill, the bipartisan Living Donor Protection Act to provide employment protections to living donors and update education material on the benefits of live organ donation, was introduced in February and is in committee.
The focus on increased transplantation efforts is welcome news for many involved in organ donations. In 2018, 3,756 kidneys were recovered but subsequently discarded, according to the Association of Organ Procurement Organizations. That accounted for about 20% of the donor kidneys available for transplant.
The discard rate in the European Union is only 10%. More of those kidneys could be used if the CMS' metrics on transplant outcomes and reimbursement were revised to offer incentives to use those kidneys, such as ones from older donors, according to Kevin Cmunt, CEO of the Gift of Hope Organ and Tissue Donor Network, in Itasca, Ill.
"We work for donor families," Cmunt said. We talk to them on the worst day of their lives … We make one implicit promise: To use it wisely. They want their loved one to live on in other people."
Marla Durben Hirsch is a freelance writer based in Potomac, Md.