PRA for the Add-On Payments for New Medical Services and Technologies Policy

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form CMS-10638 New Technology Application	Form	Modified	Available
Form CMS-10638 New Technology Tracking Form	Form	Modified	Available
CMS-10638.Supporting Statement (non-sub change request 2-7-19).docx	Supporting Statement A	Uploaded 2019-02-07	Available
Non-substantive Change Justification_CMS-10638.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2019-02-07	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
227314	Miscellaneous Tasks: Applicant Follows-Up, Applicant Gives Further Clarification of Data or Gives Further Application Information to CMS	Form	Modified	New Technology Application
227314	Miscellaneous Tasks: Applicant Follows-Up, Applicant Gives Further Clarification of Data or Gives Further Application Information to CMS	Form	Modified	New Technology Tracking Form
227314	Miscellaneous Tasks: Applicant Follows-Up, Applicant Gives Further Clarification of Data or Gives Further Application Information to CMS	Instruction	Modified

ICR Details

OMB Control No: 0938-1347	ICR Reference No: 201902-0938-007
Status: Historical Active	Previous ICR Reference No: 201706-0938-006
Agency/Subagency: HHS/CMS	Agency Tracking No: CMS-10638
Title: PRA for the Add-On Payments for New Medical Services and Technologies Policy
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/07/2019
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/07/2019
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2020	12/31/2020	12/31/2020
Responses	32	0	15
Time Burden (Hours)	1,280	0	600
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): None

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:
	82 FR 4887	01/17/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 28065	06/02/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
Miscellaneous Tasks: Applicant Follows-Up, Applicant Gives Further Clarification of Data or Gives Further Application Information to CMS	CMS-10638, CMS-10638	New Technology Tracking Form ,   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	32	15	0	0	17	0
Annual Time Burden (Hours)	1,280	600	0	0	680	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: This is a non-substantive change request. We are adjusting the estimated annual number of respondents due to larger than expected volume. No other changes have been made to the ICR.

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Annual Cost to Federal Government: $66,720

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? Uncollected

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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: 02/07/2019

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