Medicare Part C and Part D Data Validation (42 C.F.R. 422.516g and 423.514g)

Forms and Documents

Document Name	Status
Form CMS-10305 Medicare Part C and Part D Data Validation (42 C.F.R. 422.516g and 423.514g) - (CMS-10305) Form and Instruction	New
Outline for DV Procedure Manual_110910.docx Supplementary Document	2010-11-16
Standards for Selecting a DV Contractor_20101012.docx Supplementary Document	2010-11-16
Data Validation FAQs_20101019.docx Supplementary Document	2010-11-16
3 DRAFT_Interview Discussion Guide_20100219.doc Supplementary Document	2010-11-16
1 DRAFT_Document Overview_20100219.doc Supplementary Document	2010-11-16
Supporting Statement B.docx Supporting Statement B	2010-09-22
9 DRAFT Data Validation Public Comments and Lessons Learned_20100826_508.pdf Supplementary Document	2010-09-22
REV_6 DRAFT Supporting_Statement_20100826_508.docx Supporting Statement A	2010-11-16

IC Document Collections

IC ID	Document Title	Status
194762	Medicare Part C and Part D Data Validation (42 C.F.R. 422.516g and 423.514g) - (CMS-10305) Form and Instruction	New

ICR Details

OMB Control No: 0938-1115	ICR Reference No: 201009-0938-021
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Medicare Part C and Part D Data Validation (42 C.F.R. 422.516g and 423.514g)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 11/23/2010
	Date Received in OIRA: 09/30/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2013	36 Months From Approved
Responses	634	0	0
Time Burden (Hours)	237,127	0	0
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 Name of Statute: null
   Statute at Large: 18 Stat. 1860 Name of Statute: null
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AP77	Final or interim final rulemaking	75 FR 19678	04/15/2010

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 20365	04/19/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 57035	09/17/2010
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Medicare Part C and Part D Data Validation (42 C.F.R. 422.516g and 423.514g) - (CMS-10305)	CMS-10305, CMS-10305	Medicare Part C and Part D Measure Organizational Assessment Instrument ,   Findings Data Collection Form: Benefit Utilization

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ICR Summary 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	634	0	0	634	0	0
Annual Time Burden (Hours)	237,127	0	0	237,127	0	0
Annual Cost Burden (Dollars)	0	0	0	0	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: Burden estimate methodology was changed to allow for a more detailed build-up of hours and cost. Assumptions of the updated methodology are outlined in Section 12.

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Annual Cost to Federal Government: $100,000

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? Uncollected

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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: 09/30/2010

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