Medicaid Drug Utilization Review (DUR) Annual Report (CMS-R-153 and CMS-R-153a, b, and c)

Forms and Documents

Document Name	Status
Form CMS-R-153, CMS-R-1 Medicaid Drug Ulilization Review (DUR) Annual Report (CMS-R-153, CMS-R-153a, CMS-R-153b, and CMS-R-153c)(42 CFR 456.712) Form and Instruction	Modified
Supporting Statement Part A [rev 03-12-11].doc Supporting Statement A	2011-03-14

IC Document Collections

IC ID	Document Title	Status
8242	Medicaid Drug Ulilization Review (DUR) Annual Report (CMS-R-153, CMS-R-153a, CMS-R-153b, and CMS-R-153c)(42 CFR 456.712) Form and Instruction	Modified
196903	Review of Claims Data and Other Record Reports (42 CFR 456.711)	New
196902	Interventions (42 CFR 456.711)	New
196901	Claims Data and Other Record Reports Preparation (42 CFR 456.709)	New

ICR Details

OMB Control No: 0938-0659	ICR Reference No: 201102-0938-003
Status: Historical Active	Previous ICR Reference No: 199811-0938-003
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Medicaid Drug Utilization Review (DUR) Annual Report (CMS-R-153 and CMS-R-153a, b, and c)
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/21/2011
	Date Received in OIRA: 02/01/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2014	36 Months From Approved
Responses	816	0	0
Time Burden (Hours)	20,298	0	0
Cost Burden (Dollars)	0	0	0

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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.

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Authorizing Statute(s): US Code: 42 USC 1396r-8 Name of Law: Payment for Covered Outpatient Drugs
   PL: Pub.L. 101 - 508 4401 Name of Law: Reimbursement for prescribed drugs
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 63484	10/15/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 80820	12/23/2010
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Interventions (42 CFR 456.711)
Review of Claims Data and Other Record Reports (42 CFR 456.711)
Medicaid Drug Ulilization Review (DUR) Annual Report (CMS-R-153, CMS-R-153a, CMS-R-153b, and CMS-R-153c)(42 CFR 456.712)	CMS-R-153, CMS-R-153a, CMS-R-153b, and CMS-R-153c	Medicaid Drug Utilization Review Annual Report
Claims Data and Other Record Reports Preparation (42 CFR 456.709)

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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	816	0	0	766	0	50
Annual Time Burden (Hours)	20,298	0	0	-634,769	0	655,067
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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Over the years, technology has changed as has the practice of pharmacy. Therefore, CMS has revised the collection to more fully address the current practices and areas of concern with the Medicaid Pharmacy Programs. The annual report instrument is revised to remove elements pertaining to outdated practices and revised to address advances in the improved clinical practices in the profession and to address innovations going forward in the health care arena, such as eprescribing.

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Annual Cost to Federal Government: $1,418,645

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

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Common Form ICR:  No

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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: 01/25/2011

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