On the heels of the Trump administration's latest effort aimed at kidney care that includes expanding access to in-home dialysis for kidney disease care, CVS Health said Wednesday it plans to start a clinical trial of its new home dialysis system.
The clinical trial of the company's HemoCare Hemodialysis System for the administration of home hemodialysis will involve up to 70 patients at 10 sites, CVS said. Home hemodialysis helps facilitate longer, more frequent dialysis treatments compared to in-center treatments, according to the company.
CVS officials said the clinical trial for the home dialysis device represents the next step in a companywide strategy to help improve kidney disease diagnosis and management.
The company, which is one of the largest U.S. pharmacy operators and pharmacy benefit managers and also owns insurer Aetna, signaled its plans to move into kidney care a year ago, noting early initiatives would prioritize early diagnosis of the disease and the expansion of home dialysis.
And the move comes as the Trump administration unveiled July 10 five new payment models aimed at transforming kidney care. The End-Stage Renal Disease (ESRD) Treatment Choices model will launch Jan. 1. Under the model, the Centers for Medicare & Medicaid Services (CMS) intends to adjust payments to providers either upward or downward based on their home dialysis and transplantation rates, with the aim of reducing the focus on clinic dialysis, CMS officials said.
Entering the dialysis market put CVS in direct competition with DaVita, the largest kidney care provider in the U.S., and Fresenius Medical Care, the world's largest provider of dialysis services and products.
"We're working now to change the kidney care paradigm by bringing to market programs and tools to improve early detection of kidney disease and provide comprehensive education and support to help delay the transition to dialysis," Alan Lotvin, M.D., executive vice president and chief transformation officer at CVS Health, said in a statement. "For those patients who do progress to dialysis, we are working to bring a new solution to the consumer that addresses the current barriers to and limitations of existing dialysis options, and we are working closely with the U.S. Food and Drug Administration as we evaluate this device."
More than 37 million Americans have kidney disease, costing Medicare $35 billion annually related to dialysis patient care. It's estimated that 700,000 patient have ESRD, and of those more than 500,000 patients are on active dialysis, according to the company's figures.
An expanding body of scientific literature indicates clinical outcomes for hemodialysis patients can be improved if treatments are longer in duration, which can be challenging to achieve via in-center dialysis, CVS officials said.
During the clinical trial, investigators will measure the safety and performance of the hemodialysis system and will examine adverse events as well as regular tests to measure the dose efficacy of dialysis delivered by the device. The device was developed by Deka Research & Development, a firm founded by Segway inventor Dean Kamen.
"CVS Health is uniquely positioned to redefine identification, education, and treatment for chronic kidney disease, making them our ideal partner," Kamen said in a statement.
Lotvin said CVS Kidney Care, which is focused on developing kidney care solutions for commercial and government payers, is "uniquely positioned to help deliver on the core tenets of this new (Department of Health and Human Services) initiative in a way that no one else can."