Medicare plans could pay more for at-home dialysis machines, according to a proposed rule released today by the Centers for Medicare and Medicaid Services. The agency plans to expand the “transitional add-on payment adjustment for new and innovative equipment and supplies” (TPNIES), allowing CMS to cover a portion of the cost of treatment with new at-home dialysis machines.
For the past year, CMS had been looking to expand treatment setting choices for dialysis patients. With the Covid-19 pandemic, that effort has taken on a new urgency.
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More than 85% Medicare patients with end-stage renal disease travel to a facility for dialysis at least three times per week. According to CMS, they face one of the highest hospitalization rates among Medicare patients due to Covid-19.
“CMS data shows that those with ESRD have the highest rate of hospitalization of any single group, a trend consistent with having to frequently leave home to receive dialysis,” CMS Administrator Seema Verma said in a news release. “Today’s action represents a sorely needed course direction, making it easier for ESRD facilities to make new and innovative home dialysis machines available to patients who need them.”
Under the proposed rule, the device would be treated as a capital-related asset for two years, allowing CMS to cover 65% of the preadjusted per treatment amount. The proposed rule is set to go into effect in January, with comments due in September.
As published in the Federal Register, CMS also provided information about two manufacturers whose products are being considered for the program next year. They include Baxter’s Theranova 400 Dialyzer, which is seeking clearance through the FDA’s De Novo pathway, and Outset Medical’s Tablo Hemodialysis System and Cartridge, which received FDA clearance for in-home use in April.
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