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

Issue Date: September 21, 2020

We note that the information below is intended only to provide the public with a basic overview regarding the NTAP. For current requirements regarding the IPPS NTAP, including the NTAP eligibility criteria, please see the statute at sections 1886(d)(5)(K) and (L) of the Social Security Act (the “Act”), the regulations at 42 CFR sections 412.87 and 412.88, and the annual IPPS rulemakings.

Sections 1886(d)(5)(K) and (L) of the Act establish a process of identifying and ensuring adequate payment for certain new medical services and technologies (sometimes collectively referred to in this section of the CMS website as “new technologies”) under the IPPS. The regulations for add-on payments for new technologies under the IPPS can be found at 42 CFR 412.87 and 412.88. 42 CFR § 412.87(b) specifies three criteria that a new medical service or technology must meet to be eligible to receive the additional payment: (1) the medical service or technology must be new; (2) the medical service or technology must be costly such that the MS-DRG rate otherwise applicable to discharges involving the medical service or technology is determined to be inadequate; and (3) the medical service or technology must demonstrate a substantial clinical improvement over existing services or technologies. These three NTAP criteria are also referred to as the newness criterion, cost criterion, and substantial clinical improvement criterion, respectively. In addition, certain transformative new devices and antimicrobial products may qualify under an alternative inpatient new technology add-on payment pathway, as set forth at 42 CFR § 412.87(c) and (d). Please see the table at the end of this section for a summary of the eligibility requirements for each of the NTAP pathways.

Under § 412.88(a)(2)(ii), new technology add-on payments are limited to the lesser of 65% of the costs of the technology, or 65% of the amount by which the costs of the case exceed the standard MS–DRG payment (75% for a Qualified Infectious Disease Product (QIDP) or a product approved under FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD)).

As finalized in the FY 2024 IPPS final rule, per § 412.87(f)(2), applicants for NTAP must receive FDA marketing authorization for their new medical service or technology by May 1 of the year prior to the beginning of the fiscal year (FY) for which the application is being considered, except for QIDP/LPAD applicants.

Beginning with FY 2025 applications, per § 412.87(e), technologies must either be already FDA market authorized, or must have a complete and active FDA marketing authorization request at the time of NTAP application submission and must provide documentation of FDA acceptance or filing to CMS at the time of NTAP application submission, consistent with the type of FDA marketing authorization application the applicant has submitted to FDA. Additional information regarding this eligibility requirement is available in the FY 2024 and FY 2025 IPPS/LTCH PPS final rules.

NTAP Criteria

Newness Criterion

In general, a medical service or technology will no longer be considered “new” for purposes of new technology add-on payments after CMS has recalibrated the MS-DRGs, based on available data, to reflect the cost of the technology. We note that we do not consider a service or technology to be new if it is substantially similar to one or more existing technologies. That is, even if a medical product receives a new FDA approval or clearance, it may not necessarily be considered ‘‘new’’ for purposes of new technology add-on payments if it is ‘‘substantially similar’’ to another medical product that was approved or cleared by FDA and has been on the market for more than 2 to 3 years. If a technology meets all three of the following criteria, it would be considered substantially similar to an existing technology and not “new” for the purposes of NTAP:

1. The technology uses the same or a similar mechanism of action when compared to existing technology to achieve a therapeutic outcome
2. The technology has been assigned to the same MS-DRG when compared to an existing technology to achieve a therapeutic outcome
3. The new use of the technology involves the treatment of the same or similar type of disease and patient population when compared to an existing technology

Additional information regarding the newness criterion is available at § 412.87(b)(2).

Cost Criterion

In general, to qualify for a new technology add-on payment, the average charge per case for cases eligible for the technology must exceed the threshold(s) established with the release of the most recent annual IPPS final rule. The most recent version of the thresholds is available in the downloads section below.

Additional information regarding the cost criterion is available at § 412.87(b)(3).

Substantial Clinical Improvement Criterion

To qualify for a new technology add-on payment, the technology must represent an advance that substantially improves, relative to technologies previously available, the diagnosis or treatment of Medicare beneficiaries. CMS assesses the following in its evaluation of whether a technology meets the substantial clinical improvement criterion for the purposes of the NTAP:

1. The new technology offers a treatment option for a patient population unresponsive to, or ineligible for, currently available treatments.
2. The new technology offers the ability to diagnose a medical condition in a patient population where that medical condition is currently undetectable or offers the ability to diagnose a medical condition earlier in a patient population than allowed by currently available methods. There must also be evidence that the use of the new medical service or technology to make a diagnosis affects the management of the patient.
3. The use of the new medical service or technology significantly improves clinical outcomes relative to services or technologies previously available.

Additional information regarding the substantial clinical improvement criterion is available at § 412.87(b)(1).

Alternative Pathways

Certain new medical services and technologies may be eligible to apply for NTAP under an alternative pathway. Under the alternative pathways, a technology is considered to be not substantially similar to an existing technology for the purposes of NTAP, and will not need to meet the substantial clinical improvement criterion under § 412.87(b)(1).

- Alternative Pathway for Certain Transformative New Devices: For technologies that are part of FDA’s Breakthrough Devices Program and that receive marketing authorization as a Breakthrough Device for the indication covered by the Breakthrough Devices Program designation.

-  Alternative Pathway for Certain Antimicrobial Products: For technologies designated by FDA as a QIDP and that receive marketing authorization for the same indication; and for technologies approved under FDA’s LPAD and that are used for the same indication.

Additional information regarding the Alternative Pathways is available at § 412.87(c) and § 412.87(d).

 

Overview of Eligibility Criteria for NTAP Pathways	Traditional Pathway	Alternative Pathway (BTD)	Alternative Pathway (QIDP/LPAD)
Must either 1) already have FDA marketing authorization, or 2) have already received documentation from FDA that FDA has accepted (for 510k or De Novo applications) or filed (for NDA, BLA, or PMA) its marketing authorization request, at the time of NTAP application submission	Yes	Yes	Yes
Must be within the newness period1	Yes	Yes	Yes
Needs to demonstrate that it does not meet the substantial similarity criteria?	Yes	No	No
Needs to demonstrate that it meets the cost criterion?	Yes	Yes	Yes
Needs to demonstrate that it meets the substantial clinical improvement criterion?	Yes	No	No
Needs to receive FDA approval/clearance before May 1 prior to the FY for which the application is being considered?	Yes	Yes	No2

¹ The newness period begins with the availability of the product on the US market (generally, on the date of FDA approval or clearance). To be eligible for the FY 2026 application cycle, a technology’s newness period must begin no earlier than October 1, 2022.

²QIDPs and LPADs must receive FDA approval/clearance before July 1 of the FY for which it applied to NTAP.

HHS is committed to making its websites and documents accessible to the widest possible audience, including individuals with disabilities. We are in the process of retroactively making some documents accessible. If you need assistance accessing an accessible version of this document, please reach out to the guidance@hhs.gov.

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.