Medicare Program: Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) (CMS-10524)

Forms and Documents

Document Name	Status
CMS-10524 Supporting Statement A.docx Supporting Statement A	2025-09-02

IC Document Collections

IC ID	Document Title	Status
212039	Submitting a Prior Authorization Request and Mailing Medical Records	Modified

ICR Details

OMB Control No: 0938-1293	ICR Reference No: 202509-0938-002
Status: Received in OIRA	Previous ICR Reference No: 202202-0938-007
Agency/Subagency: HHS/CMS	Agency Tracking No: CPI
Title: Medicare Program: Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) (CMS-10524)
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/03/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	262,589	0
Time Burden (Hours)	131,294	0
Cost Burden (Dollars)	4,627,207	0

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Abstract: Section §414.234 of Social Security Act requires prior authorization as a condition of payment for certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS). A claim with a provisional affirmative prior authorization decision will be paid as long as all other requirements are met. A claim with a non-affirmative decision or without a decision and submitted for processing will be denied.

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Authorizing Statute(s): US Code: 42 USC 1395m Name of Law: Social Security Act
  

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:
	90 FR 24630	06/11/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 42411	09/02/2025
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Submitting a Prior Authorization Request and Mailing Medical Records

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ICR Summary of Burden

	Total Request	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	262,589	0	0	-10,716	0	273,305
Annual Time Burden (Hours)	131,294	0	0	-5,358	0	136,652
Annual Cost Burden (Dollars)	4,627,207	0	0	-188,832	0	4,816,039

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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The decrease in burden is due to a reduction in utilization.

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Annual Cost to Federal Government: $17,068,275

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: 09/03/2025

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