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

Forms and Documents

Document Name	Status
Crosswalk.doc Supplementary Document	2013-09-11
CMS-10174 Supporting Statement part A [rev 9-29-13].doc Supporting Statement A	2013-09-29

IC Document Collections

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

ICR Details

OMB Control No: 0938-0982	ICR Reference No: 201309-0938-034
Status: Historical Active	Previous ICR Reference No: 200909-0938-002
Agency/Subagency: HHS/CMS	Agency Tracking No: 20530
Title: Collection of Drug Event Data from Contracted Part D Providers For Payments
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/21/2014
	Date Received in OIRA: 09/30/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2017	36 Months From Approved
Responses	1,161,434,065	0	0
Time Burden (Hours)	2,323	0	0
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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 38986	06/28/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 53767	08/30/2013
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	1,161,434,065	0	0	0	213,552,295	947,881,770
Annual Time Burden (Hours)	2,323	0	0	0	427	1,896
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: No

Burden Reduction Due to:

Short Statement: We have adjusted our burden estimate which has increased approximately 23% from the estimate calculated in 2009. This change reflects actual numbers from the most recent 3 years of the Part D program. Additionally, there were 40 data elements in the 2009 PRA package. They increased to 54 data elements in order to reconcile payments more effectively and provide better program oversight. This change has no significant effect on our e burden estimates.

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Annual Cost to Federal Government: $11,700,000

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: 09/30/2013

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