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

Forms and Documents

Document Name	Status
Form CMS-368 State Agency Contact Form (CMS-368) Form	Modified
CMS-R-144 and 368 - Supporting Statement A (2021 version 1).docx Supporting Statement A	2021-02-27
Comment Response for PRA 0938-0582_Final.docx Supplementary Document	2021-02-27

IC Document Collections

IC ID	Document Title	Status
8197	State Agency Contact Form (CMS-368) Form	Modified
246037	CMS-R-144 – One-Time System Updates	New
212418	Quarterly Utilization Report (CMS-R-144) Instruction	Modified

ICR Details

OMB Control No: 0938-0582	ICR Reference No: 202102-0938-017
Status: Received in OIRA	Previous ICR Reference No: 202003-0938-010
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: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 03/01/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	06/30/2023
Responses	290	234
Time Burden (Hours)	13,669	12,101
Cost Burden (Dollars)	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): PL: Pub.L. 111 - 148 2501(c) Name of Law: Patient Protection and Affordable Care Act
   Statute at Large: 18 Stat. 1927 Name of Statute: null
  

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:
	85 FR 76577	11/30/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 10971	02/23/2021
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

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
CMS-R-144 – One-Time System Updates

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ICR Summary of Burden

	Total Request	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	290	234	0	56	0	0
Annual Time Burden (Hours)	13,669	12,101	0	1,344	224	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: In this 2020/2021 iteration we have revised our per response time estimate by 1 hours (for CMS-R-144) due to the new certification requirement that was captured in the previous iteration. We have also adjusted our labor rates based on more recent BLS data. Consequently, there is a slight increase in our total time and cost estimates. Effective July 1, 2021, we are updating to a new Medicaid Drug Programs (MDP) system which will now accept a delimited text file format, Comma Separated Values (.CSV), in addition to the current Text (.TXT) file format. We have also increased several file format data field sizes in order to accommodate the higher priced drugs that are entering the market. These changes in conjunction with numerous edits to verbiage are applicable to Forms CMS-304 and CMS-304a. This PRA package (0938-0676) is simultaneously being updated along with our two corresponding PRA packages (0938-0578 and 0938-0582), so that all the MDP file formats, field sizes, and verbiage will align across the MDRP. In this regard we added a one-time burden for each manufacturer to make any system updates to accommodate the updated field sizes and .CSV file formats for CMS-R-144. Form CMS-368 has been revised by removing the DUR State Contact information and description “Drug Utilization Review (DUR) Program” in the CMS-368 header. This information is now accounted for in CMS-R-153 (OMB control number: 0938-0659). See section 15 of the Supporting Statement for more details regarding the changes.

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Annual Cost to Federal Government: $735

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]? 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? 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: 03/01/2021

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