HIPAA Administrative Simplification (Non-Privacy/Security) Complaint Form (CMS-10148)

Forms and Documents

Document Name	Status
Form CMS-10148 Health Insurance Portability and Accountability Act (HIPAA) Administrative Simplification (A.S.) Complaint Form Form and Instruction	Modified
CMS-10148_Supporting_Statement_Part_A.docx Supporting Statement A	2025-09-26
HIPAA Administrative Simplification Complaint Form Crosswalk #1.pdf Supplementary Document	2021-10-15

IC Document Collections

IC ID	Document Title	Status
223444	Health Insurance Portability and Accountability Act (HIPAA) Administrative Simplification (A.S.) Complaint Form Form and Instruction	Modified

ICR Details

OMB Control No: 0938-0948	ICR Reference No: 202509-0938-028
Status: Received in OIRA	Previous ICR Reference No: 202208-0938-015
Agency/Subagency: HHS/CMS	Agency Tracking No: OIT
Title: HIPAA Administrative Simplification (Non-Privacy/Security) Complaint Form (CMS-10148)
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: 11/04/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	400	0
Time Burden (Hours)	400	0
Cost Burden (Dollars)	18,256	0

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Abstract: This revised collection of information modifies the current form to remove the HIPAA Privacy/Security complaint category section. The section is revised to read as follows: “Identify the HIPAA Non-Privacy/Security complaint category” section of the complaint form. On this revised version of the form, complainants are given an opportunity to check the “Unique Identifiers” and “Operating Rules” option to additionally categorize the type of HIPAA complaint being filed. The revised form also requests an email address for filed against entities, if available. Finally, the revised form is structured so that it be expanded to collect additional HIPAA Administrative Simplification complaint types in the future.

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Authorizing Statute(s): PL: Pub.L. 104 - 191 1300d Name of Law: Health Insurance Portability and Accountability 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 27540	06/27/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 45941	09/24/2025
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
Health Insurance Portability and Accountability Act (HIPAA) Administrative Simplification (A.S.) Complaint Form	CMS-10148	HIPAA ADMINISTRATIVE SIMPLIFICATION (NON-PRIVACY/SECURITY) COMPLAINT FORM

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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	400	0	0	379	0	21
Annual Time Burden (Hours)	400	0	0	379	0	21
Annual Cost Burden (Dollars)	18,256	0	0	18,256	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: Increase due to estimate adjustment to 400 annual submissions based on the average number of submissions received over the last three years via submission of the complaint form electronically, via U.S. mail, and the ASETT system.

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Annual Cost to Federal Government: $0

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.     Yes

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.     Yes

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: 11/04/2025

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