Medicaid Drug Rebate Program Forms (CMS-368 and CMS-R-144)

Forms and Documents

Document Name	Status
Form CMS-368 Administrative Data Report (CMS-368) Form	Modified
Form CMS-R-144 Quarterly Utilization Report (CMS-R-144) Form	New
CMS-368 and -R-144 - Supporting Statement_2014 [rev 7-22-2014 by OSORA PRA].doc Supporting Statement A	2014-07-22

IC Document Collections

IC ID	Document Title	Status
8197	Administrative Data Report (CMS-368) Form	Modified
212418	Quarterly Utilization Report (CMS-R-144) Form	New

ICR Details

OMB Control No: 0938-0582	ICR Reference No: 201407-0938-012
Status: Historical Active	Previous ICR Reference No: 201110-0938-010
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Medicaid Drug Rebate Program Forms (CMS-368 and CMS-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: 09/04/2014
	Date Received in OIRA: 07/23/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2017	36 Months From Approved	11/30/2014
Responses	234	0	224
Time Burden (Hours)	12,101	0	12,101
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:
	79 FR 25132	05/02/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 40106	07/11/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Quarterly Utilization Report (CMS-R-144)	CMS-R-144	Medicaid Drug Rebate Invoice
Administrative Data Report (CMS-368)	CMS-368	Medicaid Drug Rebate Program, State Agency Contact Form

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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	234	224	0	0	10	0
Annual Time Burden (Hours)	12,101	12,101	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: While there are no program changes, the burden for the submission of 10 Administrative Data Reports (CMS-368) was inadvertently excluded from our previous annual response estimate. The correct figure should be 234 annual responses (224 + 10).

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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: 07/23/2014

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