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COMMENT
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Days
HR
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OMB Control No:
0938-0582
ICR Reference No:
202404-0938-010
Status:
Received in OIRA
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
Date Submitted to OIRA:
04/15/2024
Requested
Previously Approved
Expiration Date
36 Months From Approved
05/31/2024
Responses
234
234
Time Burden (Hours)
12,325
12,325
Cost Burden (Dollars)
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):
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
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:
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
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
State Agency Contact Form (CMS-368)
CMS-368
State Agency Contact Form
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
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:
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
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:
04/15/2024
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