Application To Be a Qualified Entity to Receive Medicare Data for Performance Measurement / Reapplication / Annual Report Worksheet (CMS-10394)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form CMS-10394 QECP Data Source Attestation Workbook	Form and Instruction	Modified	Available
Form CMS-10394 Public Report Submission Form	Form and Instruction	Modified	Available
Form CMS-10394 Extension Request Letter	Form and Instruction	Modified	Available
Form CMS-10394 Letter of Commitment Template	Form and Instruction	Modified	Available
Form CMS-10394 Qualified Entity Certification Program Data Security Review (QECP DSR)	Form and Instruction	Modified	Available
Form CMS-10394 Phase 3 Application Readiness Checklist	Form and Instruction	Modified	Available
Form CMS-10394 Phase 2 Application Readiness Checklist	Form and Instruction	Modified	Available
Form CMS-10394 Phase 1 Application Readiness Checklist	Form and Instruction	Modified	Available
Form CMS-10394 QECP Paper-Based Reapplication Form	Form and Instruction	Modified	Available
CMS10394 QECP Supporting Statement Part A.docx	Supporting Statement A	Uploaded 2026-07-17	Available
Nakul Karkare.pdf	Public Comments	Uploaded 2026-04-05	Available
FIRN_CMS-10394_Comment.docx	Public Comments	Uploaded 2026-04-07	Available
Response to Public Comments.docx	Supplementary Document	Uploaded 2026-07-07	Available
QECP-SUPP-PRAIns-Chngs-V3 1-24_2026.docx	Supplementary Document	Uploaded 2026-07-07	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
198017	QECP Application, Reapplication, DUA and ARW	Form and Instruction	Modified	QECP Data Source Attestation Workbook
198017	QECP Application, Reapplication, DUA and ARW	Form and Instruction	Modified	Public Report Submission Form
198017	QECP Application, Reapplication, DUA and ARW	Form and Instruction	Modified	Extension Request Letter
198017	QECP Application, Reapplication, DUA and ARW	Form and Instruction	Modified	Letter of Commitment Template
198017	QECP Application, Reapplication, DUA and ARW	Form and Instruction	Modified	Qualified Entity Certification Program Data Security Review (QECP DSR)
198017	QECP Application, Reapplication, DUA and ARW	Form and Instruction	Modified	Phase 3 Application Readiness Checklist
198017	QECP Application, Reapplication, DUA and ARW	Form and Instruction	Modified	Phase 2 Application Readiness Checklist
198017	QECP Application, Reapplication, DUA and ARW	Form and Instruction	Modified	Phase 1 Application Readiness Checklist
198017	QECP Application, Reapplication, DUA and ARW	Form and Instruction	Modified	QECP Paper-Based Reapplication Form
198017	QECP Application, Reapplication, DUA and ARW	Instruction	Modified

ICR Details

OMB Control No: 0938-1144	ICR Reference No: 202607-0938-003
Status: Received in OIRA	Previous ICR Reference No: 202404-0938-006
Agency/Subagency: HHS/CMS	Agency Tracking No: OEDA
Title: Application To Be a Qualified Entity to Receive Medicare Data for Performance Measurement / Reapplication / Annual Report Worksheet (CMS-10394)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 07/17/2026

table that charts list comparision

	Requested	Previously Approved
Expiration Date	36 Months From Approved	07/31/2027
Responses	70	70
Time Burden (Hours)	5,800	5,800
Cost Burden (Dollars)	0	0

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Abstract: Section 10332 of the Patient Protection and Affordable Care Act (ACA) requires the Secretary to make standardized extracts of Medicare claims data under Parts A, B, and D available to ''qualified entities'' for the evaluation of the performance of providers of services and suppliers. The statute provides the Secretary with discretion to establish criteria to determine whether an entity is qualified to use claims data to evaluate the performance of providers of services and suppliers. We are proposing at section CFR 401.703 to evaluate an organization's eligibility across three areas: organizational and governance capabilities, addition of claims data from other sources (as required in the statute), and data privacy and security. This is the application through which organizations will provide information to CMS to determine whether they will be approved as a qualified entity.

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Authorizing Statute(s): PL: Pub.L. 114 - 110 105 Name of Law: Medicare Access and CHIP Reauthorization Act of 2015
   PL: Pub.L. 111 - 148 10332 Name of Law: Availability of Medicare Data for Performance Measurement
  

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:
	91 FR 13029	03/18/2026
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 44849	07/17/2026
Did the Agency receive public comments on this ICR? Yes

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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
QECP Application, Reapplication, DUA and ARW	CMS-10394, CMS-10394, CMS-10394, CMS-10394, CMS-10394, CMS-10394, CMS-10394, CMS-10394, CMS-10394	QECP Paper-Based Reapplication Form ,   Phase 1 Application Readiness Checklist ,   Phase 2 Application Readiness Checklist ,   Phase 3 Application Readiness Checklist ,   Qualified Entity Certification Program Data Security Review (QECP DSR) ,   Letter of Commitment Template ,   Extension Request Letter ,   Public Report Submission Form ,   QECP Data Source Attestation Workbook

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ICR Summary of Burden

table that charts list 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	70	70	0	0	0	0
Annual Time Burden (Hours)	5,800	5,800	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:

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Annual Cost to Federal Government: $466,776

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]? Yes

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: 07/17/2026

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