CMS Pub. 100-02, ch. 11, § 20.4.1

and Supplies (TPNIES)

(Rev. 13599, Issued: 01-30-26, Effective: 05-01-26, Implementation: 05-01-26)

Beginning January 1, 2020, CMS provides a transitional add-on payment adjustment for new and innovative

equipment and supplies (TPNIES) to ESRD facilities for furnishing a covered equipment or supply that

meets certain eligibility criteria.

The intent of the TPNIES, as established in § 413.236, is to facilitate beneficiary access to certain

qualifying, new and innovative renal dialysis equipment and supplies by providing an add-on payment

adjustment to support ESRD facilities in the uptake of these new and innovative equipment and supplies

under the ESRD PPS. CMS considers whether a new renal dialysis equipment or supply meets the eligibility

criteria and announces the results in the Federal Register as part of the annual ESRD PPS rulemaking.

Applications for the TPNIES under the ESRD PPS must be submitted in the electronic application intake

system, MEARIS™, accessible at https://mearis.com.gov. The annual ESRD PPS proposed rule will describe

each complete application received by the deadline. The annual ESRD PPS final rule will address public

comments received and include the final CMS determination on the TPNIES application. CMS approvals

included in the annual ESRD PPS final rule will be implemented via the ESRD PPS annual update change

request that will provide technical instructions on how ESRD facilities are to report the equipment or supply

on the ESRD claim. This change request will initiate the TPNIES period for the equipment or supply, and it

will end 2 years from the change request’s effective date. For example, any equipment or supply approved

for the TPNIES for CY 2021, the TPNIES will begin on January 1, 2021 and end on December 31, 2022.

Annual TPNIES application deadlines are available on the CMS website:

https://www.cms.gov/medicare/esrd-pps/esrd-pps-transitional-add-payment-adjustment-new-and-innovative-

equipment-and-supplies-tpnies

The TPNIES is paid to an ESRD facility for furnishing a covered equipment or supply only if the item meets

the eligibility criteria described in section 20.4.2.

Basis of Payment

The TPNIES is based on 65 percent of the MAC-determined price. The MACs, on behalf of CMS, will

establish prices for new and innovative renal dialysis equipment and supplies that meet the TPNIES

eligibility criteria using verifiable information from the following sources, if available:

1. The invoice amount, facility charges for the item, discounts, allowances, and rebates;

2. The price established for the item by other MACs and the sources of information used to establish

that price;

3. Payment amounts determined by other payers and the information used to establish those payment

amounts; and

4. Charges and payment amounts required for other equipment and supplies that may be comparable

or otherwise relevant.

Duration of the TPNIES

The TPNIES is paid for 2 calendar years, beginning on January 1 and ending on December 31. Following

payment of the TPNIES, the ESRD PPS base rate will not be modified, and the new and innovative renal

dialysis equipment or supply will be an eligible outlier service. For more information regarding the outlier

policy see §60.D of this chapter.