Medicare Part C and Part D Data Validation (42 CFR 422.516(g) and 423.514(g)) (CMS-10305)

Forms and Documents

Document Name	Status
CMS-10305_Supporting Statement A.docx Supporting Statement A	2025-09-05
60-Day Comment Response.xlsx Supplementary Document	2025-09-03
CMS-10305_Supporting Statement B_.docx Supporting Statement B	2025-09-03

IC Document Collections

IC ID	Document Title	Status
194762	Medicare Part C and Part D Data Validation (42 CFR 422.516(g) and 423.514(g)) Instruction	Modified

ICR Details

OMB Control No: 0938-1115	ICR Reference No: 202509-0938-003
Status: Received in OIRA	Previous ICR Reference No: 202504-0938-014
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Medicare Part C and Part D Data Validation (42 CFR 422.516(g) and 423.514(g)) (CMS-10305)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/09/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2025
Responses	840	840
Time Burden (Hours)	10,920	10,920
Cost Burden (Dollars)	0	0

---

Abstract: CMS' regulatory authority to require data validation is described in 42 CFR 422.516(g) and 423.514(g). Organizations contracted to offer Medicare Part C and Part D benefits are required to report data to CMS on a variety of measures. In order for the data to be useful for monitoring and performance measurement, the data must be reliable, valid, complete, and comparable among sponsoring organizations. To meet this goal, CMS has developed reporting standards and data validation specifications with respect to the Part C and Part D reporting requirements. These standards provide a review process for Medicare Advantage Organizations (MAOs), Cost Plans, and Part D sponsors to use to conduct independent data validation checks on their reported Part C and Part D data to determine their reliability, validity, completeness, and comparability in accordance with specifications developed by CMS.

---

Authorizing Statute(s): Statute at Large: 18 Stat. 1860
   Statute at Large: 18 Stat. 1857
  

Citations for New Statutory Requirements: None

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 21773	05/21/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 42970	09/05/2025
Did the Agency receive public comments on this ICR? Yes

---

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

IC Title	Form No.	Form Name
Medicare Part C and Part D Data Validation (42 CFR 422.516(g) and 423.514(g))	CMS-10305	Organizational Assessment Instrument

---

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	840	840	0	0	0	0
Annual Time Burden (Hours)	10,920	10,920	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:

---

Annual Cost to Federal Government: $300,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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

---

Common Form ICR:  No

---

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: 09/09/2025

---