Medicaid Drug Utilization Review (DUR) Program (CMS-R-153)

Forms and Documents

Document Name	Status
Form CMS-R-153 Medicaid Drug Ulilization Review (DUR) Annual Report (42 CFR 456.712 and 438.3) Form	Modified
DUR - PRA - Response to Public Comments FFY 2018.docx Supplementary Document	2018-09-26
CMS-R-153 -Supporting Statement A (rev 2).docx Supporting Statement A	2018-09-26

IC Document Collections

IC ID	Document Title	Status
8242	Medicaid Drug Ulilization Review (DUR) Annual Report (42 CFR 456.712 and 438.3) Form	Modified
196903	Review of Claims Data and Other Record Reports (42 CFR 456.711)	Modified
196902	Interventions (42 CFR 456.711)	Modified
196901	Claims Data and Other Record Reports Preparation (42 CFR 456.709)	Modified

ICR Details

OMB Control No: 0938-0659	ICR Reference No: 201809-0938-001
Status: Historical Active	Previous ICR Reference No: 201604-0938-009
Agency/Subagency: HHS/CMS	Agency Tracking No: CMCS
Title: Medicaid Drug Utilization Review (DUR) Program (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 with change	Conclusion Date: 10/29/2018
	Date Received in OIRA: 09/27/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2021	36 Months From Approved	06/30/2019
Responses	663	0	663
Time Burden (Hours)	41,004	0	20,808
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. 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.

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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

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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:
	83 FR 13130	03/27/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 33225	07/13/2018
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Medicaid Drug Ulilization Review (DUR) Annual Report (42 CFR 456.712 and 438.3)	CMS-R-153, CMS-R-153, CMS-R-153	FFS Medicaid Annual Report ,   MCO Medicaid Annual Report ,   DUR Survey Tool
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)

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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	663	663	0	0	0	0
Annual Time Burden (Hours)	41,004	20,808	0	20,196	0	0
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: No

Burden Reduction Due to:

Short Statement: The annual reporting instrument is being revised to allow states to report responses to the survey directly into the CMS hosted MDP online system, or a SurveyGizmo weblink. Additionally, for FFY 2018 and beyond, the reporting instrument will include questions for Medicaid MCOs in accordance with the requirement that states are required to report on their MCO DUR processes. We have also added some new questions to various sections in the FFS portion of the reporting instrument (a survey), and created an additional set of questions focused on MCO DUR activities. This increased the amount of information collected by about 100 percent. The overall annual report preparation burden will change due to the increase in burden of reporting both Medicaid fee-for-service and MCO DUR activity. Overall, we increased our annual burden estimate from the approved 20,808 hours to 41,004 proposed hour (see section 15 of the Supporting Statement for details).

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Annual Cost to Federal Government: $1,969,135

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]? 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: 09/27/2018

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