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OMB Control No: 0938-1347	ICR Reference No: 202309-0938-008
Status: Active	Previous ICR Reference No: 202204-0938-009
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-FFS
Title: Add-On Payments for New Medical Services and Technologies Paid Under the Inpatient Prospective Payment System (IPPS) (CMS-10638)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/29/2023
	Date Received in OIRA: 09/20/2023
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2026	36 Months From Approved	12/31/2023
Responses	62	0	62
Time Burden (Hours)	1,655	0	1,655
Cost Burden (Dollars)	0	0	0

Abstract: 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 IPPS. Section1886(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 new technology add-on payment 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.

Authorizing Statute(s): US Code: 42 USC 1395ww Name of Law: Add-On Payments for New Medical Services and Technologies Policy

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 41632	06/27/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 63579	09/15/2023
Did the Agency receive public comments on this ICR? No

Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Alternative NTAP Pathway	CMS-10638
Traditional NTAP Pathway	CMS-10638

ICR Summary of Burden

	Total Approved	Previously Approved
Annual Number of Responses	62	62
Annual Time Burden (Hours)	1,655	1,655
Annual Cost Burden (Dollars)	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The total hourly burden for all the applicants to fill out and answer questions for their applications will remain the same at 1,655 hours. This includes a total of 1,280 hours for applications on the traditional pathway and 375 hours for those in the alternative pathway. 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 and revising language for these questions to reflect policy changes effective for FY 2025, 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. These changes will not result in any net increase in burden for applicants.

Annual Cost to Federal Government: $1,351,344

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

Agency Contact: Stephan McKenzie 410 786-1943 stephan.mckenzie@cms.hhs.gov

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