Collection of Drug Event Data from Contracted Part D Providers For Payments

Forms and Documents

Document Name	Status
crosswalk.doc Supplementary Document	2009-08-25
CMS 10174 PRAfinal2 revised Oct 27 2009 trk chng.doc Supporting Statement A	2009-12-04

IC Document Collections

IC ID	Document Title	Status
43675	Collection of Drug Event Data from Contracted Part D Providers For Payments (CMS-10174) Other-Prescription Drug Event Record Layout	Modified

ICR Details

OMB Control No: 0938-0982	ICR Reference No: 200909-0938-002
Status: Historical Active	Previous ICR Reference No: 200605-0938-001
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Collection of Drug Event Data from Contracted Part D Providers For Payments
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: 12/08/2009
	Date Received in OIRA: 09/10/2009
Terms of Clearance: This ICR is approved consistent with revised supporting statement and burden adjustments. Previous terms of clearance remain in effect. The dramatic adjustments in burden suggest that these estimates are subject to wide fluctuation. To ensure that the Medicare Part D paperwork burden reflects any adjustments or changes to the program, this ICR is approved for a period of 2 years.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2011	36 Months From Approved	12/31/2009
Responses	947,881,770	0	2,418,000,000
Time Burden (Hours)	1,896	0	4,836
Cost Burden (Dollars)	0	0	0

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Abstract: CMS requires contracted Part D providers to submit prescription drug event (PDE) records as required by the Medicare Prescription Drug Improvement, and Modernization Act of 2003.

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Authorizing Statute(s): PL: Pub.L. 108 - 173 101 Name of Law: Medicare Prescription Drug, Improvement, and Modernization Act of 2003
   Statute at Large: 18 Stat. 1860 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:
0938-AN08	Final or interim final rulemaking	70 FR 4194	01/28/2005

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 27040	06/05/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 42307	08/21/2009
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Collection of Drug Event Data from Contracted Part D Providers For Payments (CMS-10174)

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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	947,881,770	2,418,000,000	0	0	-1,470,118,230	0
Annual Time Burden (Hours)	1,896	4,836	0	0	-2,940	0
Annual Cost Burden (Dollars)	0	0	0	0	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 burden estimate has been reduced approximately 40% from the original burden estimate. This change reflects actual numbers from the first 3.5 years of the Part D program.

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Annual Cost to Federal Government: $10,800,000

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]? 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

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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: 09/10/2009

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