Medicare Part D Reporting Requirements under 42 CFR section 423.505

Forms and Documents

Document Name	Status
CMS-10185.30 day comment summary_2012 Part 2 RR_07282011.xlsx Supplementary Document	2011-09-01
CMS-10185.CY2012_Part D Reporting Requirements_Draft_07222011.docx Supplementary Document	2011-09-01
CMS-10185.Summary of Revisions- 30Day Comments for Part D RR_07282011.docx Supplementary Document	2011-09-01
CMS-10185.30 day comment summary_2012 Part D RR_07212011.xlsx Supplementary Document	2011-08-10
CMS-10185. Public Comments.pdf Supplementary Document	2011-05-20
CMS-10185.Summary of Revisions.docx Supplementary Document	2011-05-20
CMS-10185.Summary of 60-day comments.xlsx Supplementary Document	2011-05-20
CMS-10185.REVISED - Supporting Statement_10192011.docx Supporting Statement A	2011-10-24

IC Document Collections

IC ID	Document Title	Status
8853	Medicare Part D Reporting Requirements CY 2009 (CMS-10185) Other-CMS-10185.CY2012_Part D Reporting Requirements_Draft_07222	Modified

ICR Details

OMB Control No: 0938-0992	ICR Reference No: 201105-0938-009
Status: Historical Active	Previous ICR Reference No: 200906-0938-002
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Medicare Part D Reporting Requirements under 42 CFR section 423.505
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: 12/12/2011
	Date Received in OIRA: 05/23/2011
Terms of Clearance: This ICR is approved consistent with the elimination of the LTC Waste reporting requirements. However, CMS is reminded that any changes to the Medicare Part D reporting requirements--even if they are implemented through guidance (e.g. the CMS Manual or the annual Call Letter) or stem from a statutory change--must be submitted for PRA approval before they are implemented.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2014	36 Months From Approved	12/31/2011
Responses	47,028	0	380,184
Time Burden (Hours)	66,498	0	157,450
Cost Burden (Dollars)	3,107,452	0	0

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Abstract: This collection provides CMS with the opportunity to exercise their statutory authority to require all Part D Sponsors (MA-PDs and PDPs) to report data related to their operational costs and services. These data will be analyzed for oversight and monitoring purposes, as well as potentially initiating other groups within the agency to perform functions such as fraud/waste/abuse investigations, audit activities, and compliance.

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Authorizing Statute(s): Statute at Large: 1 Stat. 423 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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 79000	12/17/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 19775	04/08/2011
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 D Reporting Requirements CY 2009 (CMS-10185)	CMS-10185

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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	47,028	380,184	0	-45,109	-288,047	0
Annual Time Burden (Hours)	66,498	157,450	0	-41,920	-49,032	0
Annual Cost Burden (Dollars)	3,107,452	0	0	3,107,452	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: There was an overall decrease of 333,156 responses, and an overall decrease of 94,486 burden hours associated with this revised data collection.

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Annual Cost to Federal Government: $300,000

Does this IC contain surveys, censuses, or employ statistical methods? No

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: 05/23/2011

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