Medicaid Drug Rebate Program (MDRP): Quarterly State Invoice (CMS-R-144) and State Agency Contact Form (CMS-368)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form CMS-368 State Agency Contact Form	Form	Unchanged	Available
Form CMS-368 State Agency Contact Form (CMS-368)	Form	Unchanged	Repair queued
Form CMS-R-144 Medicaid Drug Rebate Invoice	Form	Modified	Available
Form CMS-R-144 Quarterly Utilization Report (CMS-R-144)	Form	Modified	Repair queued
CMS-368 and -R-144 - Supporting Statement A (2024 version 4).docx	Supporting Statement A	Uploaded 2024-04-15	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
8197	State Agency Contact Form (CMS-368)	Form	Unchanged	State Agency Contact Form
8197	State Agency Contact Form (CMS-368)	Form	Unchanged
212418	Quarterly Utilization Report (CMS-R-144)	Form	Modified	Medicaid Drug Rebate Invoice
212418	Quarterly Utilization Report (CMS-R-144)	Form	Modified
212418	Quarterly Utilization Report (CMS-R-144)	Instruction	Modified

ICR Details

OMB Control No: 0938-0582	ICR Reference No: 202404-0938-010
Status: Active	Previous ICR Reference No: 202111-0938-011
Agency/Subagency: HHS/CMS	Agency Tracking No: CMCS
Title: Medicaid Drug Rebate Program (MDRP): Quarterly State Invoice (CMS-R-144) and State Agency Contact Form (CMS-368)
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: 06/13/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 04/15/2024
Terms of Clearance: OMB is approving this information collection request for a period of three years during which time the agency will request approval to extend or revise the collection if the agency seeks to continue the information collection activity beyond the period approved under this action.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2027	36 Months From Approved	06/30/2024
Responses	234	0	234
Time Burden (Hours)	12,325	0	12,325
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.

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Authorizing Statute(s): Statute at Large: 18 Stat. 1927
   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:
	88 FR 86905	12/15/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 24479	04/08/2024
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

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

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ICR Summary of Burden

table that charts list 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	234	0	0	0	0
Annual Time Burden (Hours)	12,325	12,325	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: $836

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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? No

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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: 04/15/2024

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