State Drug Rebate (Medicaid) (CMS-368 and R-144)

Forms and Documents

Document Name	Status
Form CMS-368 State Drug Rebate (Medicaid) Form	Modified
Record Layout.doc Supplementary Document	2009-03-06
Data Definitions.doc Supplementary Document	2009-03-06
CMS-368 and R-144 Supporting Statement.doc Supporting Statement A	2009-03-06

IC Document Collections

IC ID	Document Title	Status
8197	State Drug Rebate (Medicaid) Form	Modified

ICR Details

OMB Control No: 0938-0582	ICR Reference No: 200904-0938-007
Status: Historical Active	Previous ICR Reference No: 200604-0938-007
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: State Drug Rebate (Medicaid) (CMS-368 and R-144)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/28/2009
	Date Received in OIRA: 04/14/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2012	36 Months From Approved	07/31/2009
Responses	204	0	204
Time Burden (Hours)	9,389	0	9,389
Cost Burden (Dollars)	0	0	0

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Abstract: Section 1927 requires each State Medicaid agency to report quarterly prescription drug utilization information to drug manufacturers and to CMS. As part of this information, the State Medicaid agencies are required to report the total Medicaid rebate amount they claim they are owed by each drug manufacturer for each covered prescription drug product each quarter.

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Authorizing Statute(s): Statute at Large: 18 Stat. 1927 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:
	73 FR 77701	12/19/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 9819	03/06/2009
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
State Drug Rebate (Medicaid)	CMS-368, CMS-R-144	State Contact Agency Form ,   Medicaid Drug Rebate Invoice

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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	204	204	0	0	0	0
Annual Time Burden (Hours)	9,389	9,389	0	0	0	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: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $226,745

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: 04/14/2009

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