Medicare Part D Reporting Requirements under 42 CFR section 423.505

ICR 200711-0938-001

OMB: 0938-0992

Federal Form Document

Forms and Documents
ICR Details
0938-0992 200711-0938-001
Historical Active 200610-0938-004
HHS/CMS
Medicare Part D Reporting Requirements under 42 CFR section 423.505
Revision of a currently approved collection   No
Regular
Approved without change 02/01/2008
Retrieve Notice of Action (NOA) 11/02/2007
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
02/28/2011 36 Months From Approved 06/30/2008
330,276 0 179,368
287,132 0 123,764
0 0 0

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.

Statute at Large: 1 Stat. 423 Name of Statute: null
  
None

Not associated with rulemaking

  72 FR 31839 06/08/2007
72 FR 58096 10/12/2007
Yes

1
IC Title Form No. Form Name
Medicare Part D Reporting Requirements (CMS-10185)

  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
Yes
Miscellaneous Actions
No
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.

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Bonnie Harkless 4107865666

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
11/02/2007


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