Industry heavyweights along with a crop of startups are all chasing a lucrative home-based kidney care market.
Several of those companies have joined forces with the National Kidney Foundation, Intermountain Healthcare and the American Society of Nephrology to push for regulatory changes that will open up access to home dialysis.
Founding members of Innovate Kidney Care include Anthem, CVS Kidney Care, Home Dialyzors United (HDU), portable dialysis machine maker Outset Medical and kidney care startups Cricket Health and Strive Health.
Traditional in-clinic dialysis imposes substantial burdens on patients with kidney failure and can be both physically and emotionally demanding for them and their care partners, according to the companies.
About 37 million Americans are affected by kidney disease and 550,000 annually are on dialysis. There are options for patients facing kidney failure to self-dialyze at home, and these tools offer logistical, economic and quality of life benefits for patients.
But home options are underutilized in the U.S. and existing federal regulations make it difficult or impossible for patients to access dialysis at home, according to the companies.
The companies cite existing conditions for coverage that apply a one-size-fits-all set of requirements whether dialysis takes place in a clinic or at home. Due to these complex requirements, many organizations don't offer self-dialysis options, leaving large patient populations without access to these benefits.
Innovate Kidney Care is calling for the Centers for Medicare & Medicaid Services (CMS) to change the end-stage renal disease conditions for coverage to remove barriers to home dialysis training and support so more patients can benefit from the flexibility and personalization of home-based treatment.
The group also will campaign for CMS to differentiate regulations to expand home dialysis training, alleviate burdensome administrative tasks related to the current regulations and allow for home dialysis training and support to be delivered in a variety of healthcare settings.
“The dialysis industry has long been stagnant when it comes to delivering innovation to patients,” said Tonya Saffer, spokesperson for Innovate Kidney Care, in a statement. “We now have new, patient-centered dialysis technologies, and healthcare providers who want to innovate care delivery, in order to enable more options for where and how self-dialysis can be trained and supported."
"We can accelerate home adoption by clarifying guidance and updating outdated regulatory restrictions for both patients and providers. Innovate Kidney Care’s goal is to advocate for modernizing the conditions for coverage, empowering patients—regardless of race, ethnicity, or income—to have a choice in adopting home dialysis and reaping the benefits of having more time for living versus dialyzing," Saffer said.