Medicare Part D Reporting Requirements under 42 CFR section 423.505

Forms and Documents

Document Name	Status
Form CMS-10185 Medicare Part D Reporting Requirements (CMS-10185) Form and Instruction	Modified
CMS-10185.Summary of Revisions- 60Day Comments for 2014 Part D RR_06282013.docx Supplementary Document	2013-08-07
PRA 60-day Comment Summary_2014 Part D RR_06282013.xlsx Supplementary Document	2013-08-07
CMS-10185.Supporting_Statement_Part_A.docx Supporting Statement A	2013-08-08

IC Document Collections

IC ID	Document Title	Status
8853	Medicare Part D Reporting Requirements (CMS-10185) Form and Instruction	Modified

ICR Details

OMB Control No: 0938-0992	ICR Reference No: 201308-0938-014
Status: Historical Active	Previous ICR Reference No: 201211-0938-008
Agency/Subagency: HHS/CMS	Agency Tracking No: 20272
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 without change	Conclusion Date: 09/20/2013
	Date Received in OIRA: 08/13/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2016	36 Months From Approved	03/31/2016
Responses	8,067	0	11,269
Time Burden (Hours)	12,658	0	14,774
Cost Burden (Dollars)	577,466	0	690,389

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Abstract: MMA provides CMS the 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. Title I, Part 423, ?423.514 describes CMS' regulatory authority to establish reporting requirements for Part D sponsors. It is noted that each Part D plan sponsor must have an effective procedure to develop, compile, evaluate, and report to CMS, to its enrollees, and to the general public, at the times and in the manner that CMS requires, statistics in the following areas: (1) The cost of its operations. (2) The patterns of utilization of its services. (3) The availability, accessibility, and acceptability of its services. (4) Information demonstrating that the Part D plan sponsor has a fiscally sound operation. (5) Other matters that CMS may require. Subsection 423.505 of the MMA regulation establishes as a contract provision that Part D Sponsors must comply with the reporting requirements for submitting drug claims and related information to CMS.

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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:
	78 FR 16507	03/15/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 45203	07/26/2013
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 (CMS-10185)	CMS-10185	Medicare Part D Reporting Requirements

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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	8,067	11,269	0	-3,202	0	0
Annual Time Burden (Hours)	12,658	14,774	0	-2,116	0	0
Annual Cost Burden (Dollars)	577,466	690,389	0	-112,923	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: The number of respondents increased, but the overall number of responses, burden hours, and cost decreased. The changes are the result of added and deleted data elements from the reporting requirements.

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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: 08/13/2013

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