Issued by: Centers for Medicare & Medicaid Services (CMS)

Issue Date: October 04, 2017

 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 assessing the functionality and clinical significance of the new and innovative equipment or supply to determine eligibility for the TPNIES under our current rules. 

RESOURCES:

Refer to the final rules below for a full discussion of the TPNIES eligibility criteria, policy information, and summaries of the TPNIES applications that have been submitted and the CMS determinations that have been issued to date.

• Calendar Year 2020 ESRD PPS Final Rule, in the November 8, 2019 Federal Register (84 FR 60684 through 60698)
• Calendar Year 2021 ESRD PPS Final Rule, in the November 9, 2020 Federal Register (85 FR 71410 through 71427, 71443 through 71464, and 71477 through 71478)
• Calendar Year 2022 ESRD PPS Final Rule, in the November 8, 2021 Federal Register (86 FR 61887 through 61906)
• Calendar Year 2023 ESRD PPS Final Rule, in the November 7, 2022 Federal Register (87 FR 67191 through 67216)
• Calendar Year 2024 ESRD PPS Final Rule, in the November 6, 2023 Federal Register (88 FR 76410 through 76432)
• Calendar Year 2025 ESRD PPS Final Rule, in the November 12, 2024 Federal Register (89 FR 89162)

TPNIES Administrative Issuances:

Change Request 11869

• On October 16, 2020, CMS released Transmittal 10399 (PDF) to include revised recurring update numbers in business requirements 11869.9 and 11869.9.1. This Change Request included system changes necessary to implement the ESRD PPS TPNIES. In addition, it established a quarterly recurring update for the Healthcare Common Procedure Coding System (HCPCS) codes eligible for the TPNIES.

Change Request 12499

• On November 15, 2021 CMS released Transmittal 11120 (PDF) to replace code E1699 Dialysis equipment, not otherwise specified with code E1629 Tablo hemodialysis system for the billable dialysis service under the policy section of the business requirements form. This correction also revised business requirements 12499.6 and 12499.6.1.

Change Request 12347

• On August 11, 2021, CMS issued Transmittal 10933 (PDF) to create the system changes necessary to implement the ESRD PPS add-on payment Capital Related Assets Adjustment (CRA) for the TPNIES.
• On December 21, 2021, CMS rescinded Transmittal 10933 and replaced it with Transmittal 11166 (PDF) to provide clarifying language to the policy section that CRAs reported on the claim cannot exceed the number of treatments billed. Business requirement 12347.5.2 is updated to require claims reporting more CRAs than treatments be returned to the provider.
• On July 29, 2022, CMS rescinded Transmittal 11166 and replaced it with Transmittal 11533 (PDF) to provide clarifying language to the background and policy sections to present the policy as described in the regulation and to update the sequence of events in the example calculation. This correction clarifies that the TPNIES offset amount is subtracted from the per treatment amount before the application of the 65 percent adjustment. 

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, including our preliminary analysis of the applicant’s claims related to the substantial clinical improvement that the equipment or supply offers and other eligibility criteria for the TPNIES and any questions or concerns raised by CMS during the analysis of the application.  The annual ESRD PPS final rule will address public comments received and include the final CMS determination on the TPNIES application. In accordance with the CY 2024 ESRD PPS final rule (88 FR 76414), TPNIES eligibility criteria are analyzed in sequential order. If an application is denied, we limit our analysis in the final rule to the TPNIES criterion that is not met and any preceding criteria.  We will not include the analysis of the remaining criteria in the final rule.   

Once CMS has received 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 PPS 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, for any equipment or supply approved for the TPNIES for CY 2026, the TPNIES will begin on January 1, 2026 and end on December 31, 2027.

Issued change requests are available on the CMS Transmittal page.

REQUIREMENTS FOR NEW AND INNOVATIVE EQUIPMENT AND SUPPLIES:

Eligibility Criteria

CMS established the TPNIES under the ESRD PPS beginning January 1, 2020.

Under 42 CFR 413.236, the TPNIES is paid to an ESRD facility for furnishing a covered equipment or supply only if the item: 

1. Has been designated by CMS as a renal dialysis service under  413.171; 
2. Is new, meaning a complete application for the TPNIES has been submitted to CMS within 3 years of the date of the Food and Drug Administration (FDA) marketing authorization for the item;
3. Is commercially available by January 1 of the particular calendar year, meaning the year in which the payment adjustment would take effect; 
4. 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 non-drug and non-biological items, supplies, and services as specified in the HCPCS Level II coding guidance on the CMS website prior to the calendar year; 
5. Is innovative, meaning it meets the criteria specified in 42 C.F.R. 412.87(b)(1); and 
6. Is not a capital-related asset, except for capital-related assets that are home dialysis machines.

In addition, per § 413.236(c), FDA marketing authorization for the equipment or supply must occur by the HCPCS Level II code application deadline for biannual Coding Cycle 2 for non-drug and non-biological items, supplies, and services as specified in the HCPCS Level II coding guidance on the CMS website prior to the particular calendar year. 

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: 

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.  

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 the current calendar year’s average per treatment offset amount. 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.

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DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.