View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0938-0992
ICR Reference No:
200711-0938-001
Status:
Historical Active
Previous ICR Reference No:
200610-0938-004
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 without change
Conclusion Date:
02/01/2008
Retrieve Notice of Action (NOA)
Date Received in OIRA:
11/02/2007
Terms of Clearance:
Terms of Clearance: This collection is approved under the following terms of clearance: Upon publishing a new 60-day and 30-day Federal Register Notice, CMS will provide the public and OMB with a supplemental document that crosswalks all changes made to the revised ICR. The document should include an explanation of each change from the previous approval, the reason why the change is necessary and the citation or reference to the statute, regulation or guidance document that support the need for the change. The crosswalk should also address an increase or decrease in burden for each change.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
02/28/2011
36 Months From Approved
06/30/2008
Responses
330,276
0
179,368
Time Burden (Hours)
287,132
0
123,764
Cost Burden (Dollars)
0
0
0
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, services, and fiscal soundness. 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, Sec. 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.
Authorizing Statute(s):
Statute at Large:
1 Stat. 423
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:
72 FR 31839
06/08/2007
30-day Notice:
Federal Register Citation:
Citation Date:
72 FR 58096
10/12/2007
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 D Reporting Requirements (CMS-10185)
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
330,276
179,368
0
150,908
0
0
Annual Time Burden (Hours)
287,132
123,764
0
163,368
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:
After two years of experience with oversight and monitoring of the Reporting Requirements, CBC has identified the appropriated data needed to effectively monitor plan performance. These changes are reflected in the CY 2008 Reporting Requirement document.
Annual Cost to Federal Government:
$0
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]?
Uncollected
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
Uncollected
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
Uncollected
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Bonnie Harkless 4107865666
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:
11/02/2007
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