Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
Agenda
Reg Review
ICR
This script is used to control the display of information in this page.
Display additional information by clicking on the following:
All
Brief and OIRA conclusion
Abstract/Justification
Legal Statutes
Rulemaking
FR Notices/Comments
IC List
Burden
Misc.
Common Form Info.
Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0938-0582
ICR Reference No:
202102-0938-017
Status:
Historical Active
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
OIRA Conclusion Action:
Approved without change
Conclusion Date:
05/17/2021
Retrieve Notice of Action (NOA)
Date Received in OIRA:
03/01/2021
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
05/31/2024
36 Months From Approved
06/30/2023
Responses
290
0
234
Time Burden (Hours)
13,669
0
12,101
Cost Burden (Dollars)
0
0
0
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.
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
Citations for New Statutory Requirements:
PL: Pub.L. 111 - 148 2501(c) Name of Law: Patient Protection and Affordable Care Act
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
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
Number of Information Collection (IC) in this ICR:
3
IC Title
Form No.
Form Name
CMS-R-144 – One-Time System Updates
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
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
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.
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
Agency Contact:
Mitch Bryman 410 786-5258 Mitch.Bryman@cms.hhs.gov
Common Form ICR:
No
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
An official website of the United States government
The .gov means it's official.
The site is secure.
