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OMB Control No: 0938-0659	ICR Reference No: 201403-0938-009
Status: Historical Active	Previous ICR Reference No: 201102-0938-003
Agency/Subagency: HHS/CMS	Agency Tracking No: 21562
Title: Medicaid Drug Utilization Review (DUR) Annual Report (CMS-R-153 and CMS-R-153a and b)
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: 05/02/2014
	Date Received in OIRA: 03/20/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2017	36 Months From Approved	05/31/2014
Responses	663	0	816
Time Burden (Hours)	20,502	0	20,298
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:
	78 FR 71617	11/29/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 14711	03/17/2014
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	663	816	-128	-25
Annual Time Burden (Hours)	20,502	20,298	85	119
Annual Cost Burden (Dollars)	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: Yes

Burden Reduction Due to: Changing Forms

Short Statement: The survey instrument is being revised to address how states are monitoring clinical practices in the profession and to address innovations going forward in the health care arena. We removed request for data elements that were not considered to be useful any longer such as some demographic information, questions about therapeutic duplication that was addressed elsewhere in the questionnaire, and an attachment that was duplicative of information requested in a table and therefore we no long have a CMS-R-153c. Additionally, we decreased the overall number of problem categories and intervention types that the states had to report to on to CMS by 50 percent. We added new questions to several sections in the survey. We clarified that the annual report will now be electronically submitted directly to the Central Office (CO) instead of being submitted in hard copy through the Regional Office.

Annual Cost to Federal Government: $0

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

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