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

Forms and Documents

Document Name	Status
Form CMS-368 State Drug Rebate (Medicaid) Form	Modified
Invoice Instructions_TC_2011.doc Supplementary Document	2011-07-20
ACA Record Layout_TC_2011.docx Supplementary Document	2011-07-20
ACA Data Definitions_TC_2011.docx Supplementary Document	2011-07-20
CMS-368 & R-144 - Supporting Statement [rev 07-20-11].doc Supporting Statement A	2011-07-20

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: 201107-0938-012
Status: Historical Inactive	Previous ICR Reference No: 200904-0938-007
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: State Drug Rebate (Medicaid) (CMS-368 and R-144)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Improperly submitted and continue	Conclusion Date: 09/20/2011
	Date Received in OIRA: 07/25/2011
Terms of Clearance: This ICR must be resubmitted as being associated with a proposed rule.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2012	36 Months From Approved	04/30/2012
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 of the Social Security Act requires each State Medicaid agency to report quarterly prescription drug utilization information to drug manufacturers and to CMS via form CMS-R-144. 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. In accordance with new reporting requirements established by the Patient Protection and Affordable Care Act, form CMS-R-144 is being revised to include a new column that will enable States to distinguish between fee-for-service and managed care utilization.

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Authorizing Statute(s): Statute at Large: 18 Stat. 1927 Name of Statute: null
   PL: Pub.L. 111 - 148 2501(c) Name of Law: Patient Protection and Affordable Care Act
  

Citations for New Statutory Requirements: PL: Pub.L. 111 - 148 2501(c) Name of Law: Patient Protection and Affordable Care Act

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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:
	76 FR 21370	04/15/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 40369	07/08/2011
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 Agency Contact Form ,   Medicaid Drug Rebate Invoice

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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: Section 1927 of the Social Security Act requires each State Medicaid agency to report quarterly prescription drug utilization information to drug manufacturers and to CMS via form CMS-R-144. 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. In accordance with new reporting requirements established by the Patient Protection and Affordable Care Act, form CMS-R-144 is being revised to include a new column that will enable States to distinguish between fee-for-service and managed care utilization.

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Annual Cost to Federal Government: $87,500

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]? Yes

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: 07/25/2011

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