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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:
0938-0659
ICR Reference No:
201604-0938-009
Status:
Historical Active
Previous ICR Reference No:
201403-0938-009
Agency/Subagency:
HHS/CMS
Agency Tracking No:
Title:
Medicaid Drug Utilization Review (DUR) Annual Report (CMS-R-153)
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:
06/16/2016
Retrieve Notice of Action (NOA)
Date Received in OIRA:
04/15/2016
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
06/30/2019
36 Months From Approved
05/31/2017
Responses
663
0
663
Time Burden (Hours)
20,808
0
20,502
Cost Burden (Dollars)
0
0
0
Abstract:
Section 4401 of the Omnibus Budget Reconciliation Act of 1990 and section 1927(d) of the Social Security Act requires States to provide for a Medicaid Drug Utilization Review (DUR) program for covered outpatient drugs. The DUR program is required to assure that prescriptions are appropriate, medically necessary and are not likely to result in adverse medical results. Each State DUR program must consist of prospective drug use review, retrospective drug use review, data assessment of drug use against predetermined standards, and ongoing educational outreach activities. In addition, States are required to submit an annual DUR program report that includes a description of the nature and scope of State DUR activities as outlined in the statute and regulations. The Centers for Medicare and Medicaid Services, Center for Medicaid, CHIP and Survey and Certification, is requesting a 3-year approval of the State data collection requirements, the CMS forms CMS-R-153, CMS-R-153a, CMS-R-153b, and CMS-R-153c data collection instruments with instructions and the annual reporting contained in the Medicaid Drug Utilization Review regulation.
Authorizing Statute(s):
PL:
Pub.L. 101 - 508 4401
Name of Law: Reimbursement for prescribed drugs
US Code:
42 USC 1396r-8
Name of Law: Payment for Covered Outpatient Drugs
Citations for New Statutory Requirements:
None
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:
81 FR 5014
01/29/2016
30-day Notice:
Federal Register Citation:
Citation Date:
81 FR 21552
04/12/2016
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
4
IC Title
Form No.
Form Name
Claims Data and Other Record Reports Preparation (42 CFR 456.709)
Interventions (42 CFR 456.711)
Medicaid Drug Ulilization Review (DUR) Annual Report (CMS-R-153)
CMS-R-153
Medicaid Drug Utilization Review Annual Report
Review of Claims Data and Other Record Reports (42 CFR 456.711)
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
663
663
0
0
0
0
Annual Time Burden (Hours)
20,808
20,502
0
0
306
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:
The estimated impact of replacing table 1 decreased the amount of information the states had to report to CMS by 20 percent. We have also added new questions to several sections in the report, which increased the amount of information collected by 20 percent. Consequently, the overall annual report preparation burden is unchanged. We adjusted the time for vendors to create exception reports by 60 percent (in aggregate, 510 currently approved hours vs 816 proposed hours).
Annual Cost to Federal Government:
$995,210
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
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?
Uncollected
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:
04/15/2016
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