Add-On Payments for New Medical Services and Technologies Paid Under the Inpatient Prospective Payment System (IPPS) (CMS-10638)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form CMS-10638 New Technology Application	Form	New	Available
Form CMS-10638 Alternative NTAP Pathway	Form	New	Repair queued
Form CMS-10638 New Technology Application	Form	Modified	Available
Form CMS-10638 Traditional NTAP Pathway	Form	Modified	Repair queued
CMS-10638 Supporting Statement Part A 2023_.docx	Supporting Statement A	Uploaded 2023-09-20	Repair queued
NTAP Crosswalk FY 2025 Program 30d clean.pdf	Supplementary Document	Uploaded 2023-09-14	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
262237	Alternative NTAP Pathway	Form	New	New Technology Application
262237	Alternative NTAP Pathway	Form	New
227314	Traditional NTAP Pathway	Form	Modified	New Technology Application
227314	Traditional NTAP Pathway	Form	Modified

ICR Details

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
Retrieve Notice of Action (NOA)	Date Received in OIRA: 09/20/2023
Terms of Clearance:

table that charts list comparision

	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

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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.

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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

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

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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

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

table that charts list of burden

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

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ICR Summary of Burden

table that charts list of burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	62	62	0	0	0	0
Annual Time Burden (Hours)	1,655	1,655	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	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.

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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

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 09/20/2023

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