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

Forms and Documents

Document Name	Status
Response to Comments to OMB CMS_10305 090914.doc Supplementary Document	2014-09-24
CMS-10305 - Supporting Statement B [rev 9-24-2014 by OSORA PRA].docx Supporting Statement B	2014-09-24
CMS-10305 - Supporting Statement A [rev 9-24-2014 by OSORA PRA].docx Supporting Statement A	2014-09-24

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) Instruction	Modified

ICR Details

OMB Control No: 0938-1115	ICR Reference No: 201409-0938-014
Status: Historical Active	Previous ICR Reference No: 201311-0938-014
Agency/Subagency: HHS/CMS	Agency Tracking No: 20897
Title: Medicare Part C and Part D Data Validation (42 CFR 422.516g and 423.514g) (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 with change	Conclusion Date: 11/24/2014
	Date Received in OIRA: 09/26/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2017	36 Months From Approved	02/28/2017
Responses	706	0	657
Time Burden (Hours)	202,578	0	179,301
Cost Burden (Dollars)	0	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. 1857 Name of Statute: null
   Statute at Large: 18 Stat. 1860 Name of Statute: null
  

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:
	79 FR 33927	06/13/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 56379	09/19/2014
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 C.F.R. 422.516g and 423.514g) - (CMS-10305)	CMS-10305, CMS-10305	Appendix 2: Organizational Assessment Instrument ,   Appendix 5: Findings Data Collection Form

---

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	706	657	0	49	0	0
Annual Time Burden (Hours)	202,578	179,301	0	23,277	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: The changes in the data validation program for the annual 2015-2017 data validation cycles will result in an estimated increase in the level of effort by 23,277 hours (13 percent) and an estimated increase in the cost to industry of $358,713 (2.4 percent). This increase in burden is attributed to an increased number of sponsoring organizations and the average number of contracts per sponsor.. The number of reporting sections undergoing data validation decreased from 11 to 9, but the level of effort per reporting section increased because of increases in the number of data elements. Organizations contracted to offer Medicare Part C and Part D benefits are required to report data to the Centers for Medicare & Medicaid Services (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 data validation checks on their reported Part C and Part D data. The current ICR needs to be revised to reflect decreases in the number of reporting sections being validated and an increase in the average number of data elements per reporting section for the period of 2015 -2017.

---

Annual Cost to Federal Government: $300,000

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

---

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: 09/26/2014

---