Healio Special Report: Health Care and Politics

Healio Special Report: Health Care and Politics


CMS Fact Sheet

July 08, 2020
2 min read

CMS expands add-on payment adjustment for new equipment to spur home dialysis growth


CMS Fact Sheet

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On July 6, CMS issued a proposed rule for the End-stage Renal Disease Prospective Payment System, which expands its transitional add-on payment adjustment for innovative dialysis equipment and supplies, focusing on items for home use.

More specifically, CMS is proposing to broaden eligibility for the transitional add-on payment adjustment for new and innovative equipment and supplies (TPNIES), while limiting these payments to machines used for home dialysis.

Source: Adobe Stock

In the proposed rule, CMS wrote: “As more ESRD patients and their nephrologists and other clinicians opt for home dialysis modalities, we would seek to support ESRD facility use and beneficiary access to the latest technological improvements to hemodialysis and peritoneal dialysis home dialysis machines.”

According to a fact sheet released by CMS, applications will be evaluated to determine whether the home dialysis machine “represents an advance that substantially improves, relative to renal dialysis services previously available, the diagnosis or treatment of Medicare beneficiaries.” Other requirements under § 413.236(b) would also have to be met.

CMS stated that the goal of increasing home dialysis will, in part, be done by focusing on entirely new equipment, not just considering one part of a machine to be “new.”

“We propose to define ‘home dialysis machines’ at § 413.236(a)(2) as hemodialysis machines and peritoneal dialysis cyclers in their entirety, meaning that one new part of a machine does not make the entire capital-related asset new, that receive FDA marketing authorization for home use and when used in the home for a single patient,” CMS wrote. “FDA provides a separate marketing authorization for equipment intended for home use, and this proposal is focused on supporting efforts to increase home dialysis.”

In addition, Medicare Administrative Contractors (MACs) would establish the basis payment of the TPNIES for these home dialysis machines through steps designated by CMS, with CMS paying 65% of the MAC-determined pre-adjusted per treatment amount for 2 years. The fact sheet noted that after the 2-year TPNIES period ends, “the home dialysis machines would not become eligible outlier services and no change would be made to the ESRD PPS base rate.”

In a related press release, CMS Administrator Seema Verma, commented on these proposed changes.

“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,” she said.

Kidney Care Partners also expressed continued support for TPNIES.

“As the administration has recognized, fostering innovation is critically important to providing access to new therapy options for patients with kidney failure who require dialysis,” the organization said in a statement released about the PPS rule.

The full rule can be found here.