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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form CMS-10305 Special Needs Plans (SNPs) Care Management 2022	Form and Instruction	Modified	Available
Form CMS-10305 Organization Determinations/Reconsiderations (Part C) 2022	Form and Instruction	Modified	Available
Form CMS-10305 Medication Therapy Management (MTM) Programs (Part D) 2022	Form and Instruction	Modified	Available
Form CMS-10305 Improving Drug Utilization Review Controls (Part D) 2022	Form and Instruction	Modified	Available
Form CMS-10305 Coverage Determinations and Redeterminations (Part D) 2022	Form and Instruction	Modified	Available
Form CMS-10305 Grievances (Part D) _2022	Form and Instruction	Modified	Available
Form CMS-10305 Grievances (Part C)_2022	Form and Instruction	Modified	Available
Form CMS-10305 Organizational Assessment Instrument	Form and Instruction	Modified	Available
Supporting Statement A.docx	Supporting Statement A	Uploaded 2022-08-04	Repair queued
Supporting Statement B.docx	Supporting Statement B	Uploaded 2022-08-04	Repair queued
60-Day Comment Response Document_20220628_508.pdf	Supplementary Document	Uploaded 2022-08-04	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
194762	Medicare Part C and Part D Data Validation (42 CFR 422.516(g) and 423.514(g))	Form and Instruction	Modified	Special Needs Plans (SNPs) Care Management 2022
194762	Medicare Part C and Part D Data Validation (42 CFR 422.516(g) and 423.514(g))	Form and Instruction	Modified	Organization Determinations/Reconsiderations (Part C) 2022
194762	Medicare Part C and Part D Data Validation (42 CFR 422.516(g) and 423.514(g))	Form and Instruction	Modified	Medication Therapy Management (MTM) Programs (Part D) 2022
194762	Medicare Part C and Part D Data Validation (42 CFR 422.516(g) and 423.514(g))	Form and Instruction	Modified	Improving Drug Utilization Review Controls (Part D) 2022
194762	Medicare Part C and Part D Data Validation (42 CFR 422.516(g) and 423.514(g))	Form and Instruction	Modified	Coverage Determinations and Redeterminations (Part D) 2022
194762	Medicare Part C and Part D Data Validation (42 CFR 422.516(g) and 423.514(g))	Form and Instruction	Modified	Grievances (Part D) _2022
194762	Medicare Part C and Part D Data Validation (42 CFR 422.516(g) and 423.514(g))	Form and Instruction	Modified	Grievances (Part C)_2022
194762	Medicare Part C and Part D Data Validation (42 CFR 422.516(g) and 423.514(g))	Form and Instruction	Modified	Organizational Assessment Instrument
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: 202208-0938-008
Status: Historical Active	Previous ICR Reference No: 202109-0938-004
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: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/28/2022
Retrieve Notice of Action (NOA)	Date Received in OIRA: 08/05/2022
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2025	36 Months From Approved	04/30/2023
Responses	793	0	761
Time Burden (Hours)	21,535	0	20,946
Cost Burden (Dollars)	0	0	0

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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.

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

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:
	87 FR 20416	04/07/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 47749	08/04/2022
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
Medicare Part C and Part D Data Validation (42 CFR 422.516(g) and 423.514(g))	CMS-10305, CMS-10305, CMS-10305, CMS-10305, CMS-10305, CMS-10305, CMS-10305, CMS-10305	Organizational Assessment Instrument ,   Grievances (Part C)_2022 ,   Grievances (Part D) _2022 ,   Coverage Determinations and Redeterminations (Part D) 2022 ,   Improving Drug Utilization Review Controls (Part D) 2022 ,   Medication Therapy Management (MTM) Programs (Part D) 2022 ,   Organization Determinations/Reconsiderations (Part C) 2022 ,   Special Needs Plans (SNPs) Care Management 2022

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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	793	761	0	0	32	0
Annual Time Burden (Hours)	21,535	20,946	0	0	589	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: Burden has increased due to the growth in the number of contracts (MA-only, PDPs, and MA-PDPs) validated during the most recent DV cycle. Total Number of CMS Contracts has increased from 761 to 793.

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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

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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: 08/05/2022

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