June 27 -- The Centers for Medicare & Medicaid Services (CMS) invites comments by August 28, 2023 regarding application for Add-On Payments for New Medical Services and Technologies Paid Under the Inpatient Prospective Payment System (IPPS).
For consideration for add-on payments for new medical services or technologies for FY 2019 and subsequent Federal Fiscal Years, applicants were required to submit a formal new technology add-on payment (NTAP) application (which included a tracking form) both electronically and in hard copy. The application included questions regarding the three criteria that applicants must answer in order for CMS to determine if the applicant is eligible for add-on payments for new medical services or technologies for the upcoming fiscal year. For the convenience of the applicants, the application was posted on the CMS website in multiple electronic formats. Applicants were required to submit an electronic copy and hard copy to CMS by the deadline posted on the CMS website.
Beginning with FY 2024 applications, CMS implemented an electronic application intake system for NTAP applications within the Medicare Electronic Application Request Information System (MEARISTM) in order to make our current application process more efficient. The electronic NTAP application in MEARIS™ used an application/form that was very similar to the previous paper application (CMS 10638) except for a few minor changes to either accommodate the web format or further provide simplification or clarification of the existing application questions. Beginning with FY 2024 applications and for subsequent application cycles, CMS only accepts NTAP applications submitted via MEARIS™.
For FY 2025, we are updating the NTAP MEARIS™ application to further simplify or clarify existing application questions, including: a) reorganizing the Coding, Cost, and Volume sections of the application to improve flow, b) simplifying the FDA section questions, c) simplifying the way applicants can include codes and MS-DRGs, and d) adding additional explanatory notes in multiple sections of the application to improve understanding of the question. We are requesting renewal of PRA approval from OMB by the end of July to meet our statutory rulemaking deadlines. We estimate receiving approximately 62 applications annually.
Sections 1886(d) (5) (K) and (L) of the Act establish a process of identifying and ensuring adequate payment for new medical services and technologies (sometimes collectively referred to in this section as “new technologies”) under the Inpatient Prospective Payment System (IPPS). Section 1886(d)(5)(K)(vi) of the Act specifies that a medical service or technology will be considered new if it meets criteria established by the Secretary after notice and opportunity for public comment. Section 1886(d)(5)(K)(ii)(I) of the Act specifies that a new medical service or technology may be considered for NTAP if, “based on the estimated costs incurred with respect to discharges involving such service or technology, the DRG prospective payment rate otherwise applicable to such discharges under this subsection is inadequate.”
The regulations at 42 CFR 412.87 implement these provisions and specify three criteria for a new medical service or technology 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 DRG rate otherwise applicable to discharges involving the medical service or technology is determined to be inadequate; and (3) the service or technology must demonstrate a substantial clinical improvement over existing services or technologies. We refer to applications that must meet all three of these criteria as traditional NTAP pathway applications.
In the FY 2020 IPPS final rule (84 FR 42292 through 42297) and FY 2021 IPPS final rule, we adopted an alternative NTAP pathway for certain devices and certain antimicrobial products. Specifically, applications received for new technology add-on payments under the alternative pathway need to meet the cost criterion (that is, the medical product must be costly such that the DRG rate otherwise applicable to discharges involving the medical product is determined to be inadequate). These applications do not have to meet the substantial clinical improvement criterion and therefore do not have to provide this information at the time of application. The alternative NTAP pathway is available: (1) for a medical device that is part of Federal Drug Administration’s (FDA’s) Breakthrough Devices Program and that receives marketing authorization as a Breakthrough Device for the indication covered by the Breakthrough Device designation. (2) for a product that is designated by FDA as a Qualified Infectious Disease Product (QIDP) and that receives marketing authorization for the same indication; and for a product approved under FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) and that is used for the same indication. To implement these, we revised the regulations at 42 CFR 412.87.
We use the application in order to determine if a technology meets the relevant NTAP criteria.
NTAP:
https://www.cms.gov/medicare/medicare-fee-for-service-payment/acuteinpatientpps/newtech
Draft data collection instrument and technical documentation:
https://www.cms.gov/regulations-and-guidance/legislation/paperworkreductionactof1995/pra-listing-items/cms-10638
FRN:
https://www.federalregister.gov/d/2023-13659