The intent of the TPNIES, as established in 42 CFR 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 new and innovative equipment and supplies under the ESRD PPS.
This page provides guidance on our TPNIES policy. This page also describes the information that must be sent to CMS when requesting the TPNIES for a new and innovative renal dialysis equipment or supply. The goal is for CMS to have the information necessary for determining the functionality and clinical significance of the new and innovative equipment or supply to determine eligibility for the TPNIES.
Refer to the final rules in the November 8, 2019 Federal Register (84 FR 60681 through 60698) and November 9, 2020 Federal Register (85 FR 71410 through 71464) for a full discussion of the criteria and other policy information regarding the TPNIES.
IMPORTANT DEADLINES FOR CY 2022 APPLICATIONS FOR THE TPNIES IN CY 2023:
February 1, 2022
- A complete application (PDF) must be received by CMS.
HCPCS Level II Code Application Deadline for Biannual Coding Cycle 2 for DMEPOS items and services (as specified in the HCPCS Level II coding guidance on the CMS website) prior to the calendar year.
- The equipment or supply must have FDA marketing authorization.
- The HCPCS application must be submitted.
TIMELINE FOR DETERMINATION & PAYMENT:
CMS will consider whether a new renal dialysis equipment or supply meets the eligibility criteria and announce the results in the Federal Register as part of the annual ESRD PPS rulemaking. 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.
Once CMS has all of the required information for equipment and supplies eligible for the TPNIES, we will issue a change request with billing guidance that will provide notice to the dialysis community that the equipment or supply is eligible for the TPNIES as of January 1 and 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 any equipment or supply approved for the TPNIES for CY 2023, the TPNIES will begin on January 1, 2023 and end on December 31, 2024.
Issued change requests are available on the CMS Transmittal page.
REQUIREMENTS FOR NEW AND INNOVATIVE EQUIPMENT AND SUPPLIES:
Beginning January 1, 2020, the TPNIES is paid to an ESRD facility for furnishing a covered equipment or supply only if the item:
- Has been designated by CMS as a renal dialysis service under § 413.171;
- *Is new, meaning within 3 years beginning on the date of the Food and Drug Administration (FDA) marketing authorization;
- Is commercially available by January 1 of the particular calendar year, meaning the year in which the payment adjustment would take effect;
- *Has a complete Healthcare Common Procedure Coding System (HCPCS) Level II code application submitted in accordance with the HCPCS Level II coding procedures on the CMS website, by the HCPCS Level II code application deadline for biannual Coding Cycle 2 for durable medical equipment, orthotics, prosthetics and supplies (DMEPOS) items and services as specified in the HCPCS Level II coding guidance on the CMS website prior to the calendar year;
- *Is innovative, meaning it meets the criteria specified in 42 C.F.R. § 412.87(b)(1) of this chapter; and
- *Is not a capital-related asset, except for capital-related assets that are home dialysis machines.
*CMS finalized these eligibility criteria in the CY 2021 ESRD PPS final rule (codified at 42 CFR 413.236). For the previous TPNIES eligibility criteria, in effect for CY 2020, please see the CY 2020 ESRD PPS final rule (84 FR 60681 through 60698).
Basis of Payment
The TPNIES is based on 65 percent of the Medicare Administrative Contractor (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 of information, if available:
- The invoice amount, facility charges for the item, discounts, allowances, and rebates;
- The price established for the item by other MACs and the sources of information used to establish that price;
- Payment amounts determined by other payers and the information used to establish those payment amounts; and
- Charges and payment amounts required for other equipment and supplies that may be comparable or otherwise relevant.
For capital-related assets that are home dialysis machines, CMS will pay 65 percent of the MAC-determined pre-adjusted per treatment amount reduced by an average per treatment offset amount of $9.32 for 2 calendar years. 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. For more information on the payment basis for capital-related assets that are home dialysis machines, please see the CY 2021 ESRD PPS final rule (85 FR 71399).
The TPNIES is paid for 2 calendar years, beginning on January 1 and ending on December 31.