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:
202006-0938-018
Status:
Historical Inactive
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:
Comment filed on proposed rule and continue
Conclusion Date:
11/06/2020
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/30/2020
Terms of Clearance:
Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
06/30/2023
36 Months From Approved
06/30/2023
Responses
234
0
234
Time Burden (Hours)
12,101
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):
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:
0938-AT82
Proposed rulemaking
85 FR 37286
06/19/2020
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
85 FR 37286
06/19/2020
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
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Changing Regulations
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
This 2020 information collection request is associated with our June 19, 2020, proposed rule (CMS-2482-P, RIN 0938-AT82). Under proposed § 447.511(b) states, territories, and the District of Columbia would be required to ensure by certification that the quarterly rebate invoices sent to manufacturers that participate in the MDRP no later than 60 days after the end of each rebate period via CMS-R-144 (Quarterly Medicaid Drug Rebate Invoice), mirrors the data sent to us. Under proposed § 447.511(d) states would now be required to certify that their SDUD meets the requirements specified under proposed § 447.511(e) via a certification statement. We believe the certification would not impose a significant burden as we will provide systems access to state certifiers to log in once per quarter to certify their SDUD report. Certifiers would have to apply for a CMS user ID and password, and keep current with required annual computer-based training, as current state staff with access to our systems must do. To comply with the proposed certification requirements, States must already have system edits in place to find and correct SDUD outliers prior to reporting to manufacturers and CMS. We estimate it would take 5 hours for the State Medicaid Director, Deputy State Medicaid Director, another individual with equivalent authority, or an individual with directly delegated authority from one of the above to obtain current CMS systems access. In aggregate we estimate a one-time system ID/password access burden of 280 hours (5 hr x 56 respondents). We also estimate an additional annual burden of 2 hours (or 30 minutes/quarter) for a chief executive to certify such data and to add the state data certification language in their submission. In aggregate we estimate a burden of 112 hours (2 hr x 56 respondents). In addition to the changes associated with the proposed rule, we are also updating our cost estimates based on more recent BLS wage figures. Overall, our cost estimate has increased by $82,821 (from $615,526 to $698,347).
Annual Cost to Federal Government:
$728
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:
06/30/2020
An official website of the United States government
The .gov means it's official.
The site is secure.
