Medicaid Drug Utilization Review (DUR) Annual Report (CMS-R-153)

Forms and Documents

Document Name	Status
Form CMS-R-153 Medicaid Drug Ulilization Review (DUR) Annual Report (CMS-R-153) Form	Modified
CMS-R-153 - Supporting Statement A [rev 04-14-2016 by OSORA PRA].docx Supporting Statement A	2016-04-15

IC Document Collections

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

ICR Details

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
	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
Medicaid Drug Ulilization Review (DUR) Annual Report (CMS-R-153)	CMS-R-153	Medicaid Drug Utilization Review Annual Report
Claims Data and Other Record Reports Preparation (42 CFR 456.709)
Interventions (42 CFR 456.711)
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

---

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

---