View Information Collection Request (ICR) Package
Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
Agenda
Reg Review
ICR
This script is used to control the display of information in this page.
Display additional information by clicking on the following:
All
Brief and OIRA conclusion
Abstract/Justification
Legal Statutes
Rulemaking
FR Notices/Comments
IC List
Burden
Misc.
Common Form Info.
Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
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:
200906-0938-002
Status:
Historical Active
Previous ICR Reference No:
200902-0938-002
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 without change
Conclusion Date:
10/13/2009
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/08/2009
Terms of Clearance:
This ICR is approved without change. However, CMS is reminded that any changes to these reporting requirements--even if they are implemented through sub-regulatory guidance (e.g. the CMS Manual or the annual Call Letter) or stem from a statutory change--must be approved before they are implemented. Previous terms of clearance apply.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
10/31/2011
36 Months From Approved
02/28/2011
Responses
380,184
0
330,276
Time Burden (Hours)
157,450
0
287,132
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:
74 FR 3051
01/16/2009
30-day Notice:
Federal Register Citation:
Citation Date:
74 FR 24013
05/22/2009
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 CY 2009 (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
380,184
330,276
0
49,908
0
0
Annual Time Burden (Hours)
157,450
287,132
0
-129,682
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:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
After additional experience with oversight and monitoring of data collected via the Part D Reporting Requirements, CMS has identified the appropriate data needed to effectively monitor plan performance. Revisions to the collection instrument are subsequent to both new legislation, and changes to agency policy or guidance. Decreases in the reporting frequency and level of data reported, and changes to streamline existing sections are the primary reasons for the overall decrease in the reporting burden. These changes are reflected in the revised 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)?
No
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:
06/08/2009
An official website of the United States government
The .gov means it's official.
The site is secure.
