[Medicaid] 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
CMS-R-153 - Supporting Statement A (CMS-4208-P version 4).docx Supporting Statement A	2025-01-15
CMS-R-153 - Supporting Statement B (2024 version 1).docx Supporting Statement B	2024-09-04

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
273683	Proposed (CMS-4208-P, RIN 0938-AV40) ICRs Regarding Part D Coverage of Anti-Obesity Medications (§ 423.100) and Application to the Medicaid Program	New
196903	Review of Claims Data and Other Record Reports (42 CFR 456.711)	Unchanged
196902	Interventions (42 CFR 456.711)	Unchanged
196901	Claims Data and Other Record Reports Preparation (42 CFR 456.709)	Unchanged

ICR Details

OMB Control No: 0938-0659	ICR Reference No: 202501-0938-007
Status: Received in OIRA	Previous ICR Reference No: 202409-0938-002
Agency/Subagency: HHS/CMS	Agency Tracking No: CMCS
Title: [Medicaid] 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	Date Submitted to OIRA: 01/15/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2027
Responses	715	676
Time Burden (Hours)	43,420	41,860
Cost Burden (Dollars)	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:
0938-AV40	Proposed rulemaking	89 FR 99340	12/10/2024

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 99340	12/10/2024
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

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 (42 CFR 456.712 and 438.3)	CMS-R-153, CMS-R-153, CMS-R-153, CMS-R-153	FFS Annual Surveys ,   MCO Annual Surveys ,   State DUR Agency Contact Form ,   Abbreviated MCO Surveys
Proposed (CMS-4208-P, RIN 0938-AV40) ICRs Regarding Part D Coverage of Anti-Obesity Medications (§ 423.100) and Application to the Medicaid Program
Review of Claims Data and Other Record Reports (42 CFR 456.711)

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ICR Summary of Burden

	Total Request	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	715	676	0	39	0	0
Annual Time Burden (Hours)	43,420	41,860	0	1,560	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: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This iteration is associated with our December 10, 2024 (89 FR 99340) proposed rule (CMS-4208-P, RIN 0938-AV40) regarding Part D coverage of anti-obesity medications (§ 423.100) and its application to the Medicaid program. There will be a burden for the state Medicaid programs that do not already cover AOMs when used for weight reduction or chronic weight management for Medicaid enrollees with obesity to modify their existing coverage and reimbursement policies and criteria to remove such exclusion of AOMs. Overall, this iteration would impact 39 States and add a one-time burden of 39 responses, 1,560 hours, and $66,846. See section 15 of the Supporting Statement for details

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Annual Cost to Federal Government: $2,282,964

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? No

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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: 01/15/2025

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