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OMB Control No: 0938-1388	ICR Reference No: 202305-0938-016
Status: Active	Previous ICR Reference No: 202007-0938-012
Agency/Subagency: HHS/CMS	Agency Tracking No: CMMI
Title: Value in Opioid Use Disorder Treatment Demonstration (CMS-10728)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/16/2023
	Date Received in OIRA: 05/31/2023
Terms of Clearance: CMS addressed the previous terms of clearance via its SORN.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2026	36 Months From Approved	12/31/2023
Responses	388	0	1,100
Time Burden (Hours)	282	0	856
Cost Burden (Dollars)	0	0	0

Abstract: Value in Opioid Use Disorder Treatment (Value in Treatment) is a 4-year demonstration program authorized under section 1866F of the Social Security Act (Act), which was added by section 6042 of the SUPPORT Act. The purpose of Value in Treatment is to “increase access of applicable beneficiaries to opioid use disorder treatment services, improve physical and mental health outcomes for such beneficiaries, and to the extent possible, reduce Medicare program expenditures.” As required by statute, Value in Treatment will be implemented no later than January 1, 2021. All Value in Treatment participants are required to cooperate with efforts to conduct the independent evaluation of the demonstration program. This may include but not limited to participation in surveys, interviews, site visits, focus groups, and other activities that CMS determines necessary to conduct a comprehensive evaluation. CMS anticipates all data collected from participants will be reported at an aggregate-level data so as to avoid the disclosure of private and sensitive data of specific participants. The evaluation will assess the extent that the demonstration program: a) Reduced hospitalizations and emergency department visits; b) Increased use of medication-assisted treatment for opioid use disorders; c) Improved health outcomes of individuals with OUD, including reducing the incidence of Hepatitis C and HIV; d) Did not increase the total spending on items and services; e) Reduced deaths from opioid overdose; and f) Reduced the utilization of inpatient residential treatment.

Authorizing Statute(s): PL: Pub.L. 115 - 271 6042 Name of Law: Opioid Use Disorder Treatment Demonstration Program
US Code: 42 USC 1866F Name of Law: Opioid Use Disorder Treatment Demonstration Program

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:
	88 FR 15035	03/10/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 34502	05/30/2023
Did the Agency receive public comments on this ICR? No

Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Beneficiary Notification	CMS-10728
Beneficiary Survey	CMS-10728
Participant Compliance Audit
Participant Financial	CMS-10728
Participant Survey	CMS-10728
Participation Agreement	CMS-10728
Request for Application	CMS-10728, CMS-10728, CMS-10728	, ,

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	388	1,100	-100	-612
Annual Time Burden (Hours)	282	856	-200	-374
Annual Cost Burden (Dollars)	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This PRA submission reflects actual, rather than anticipated, provider numbers. This new approach shows a a decrease (from 100 to 47) in actual participation, and therefore there is a slight decrease in burden measured hourly and financially. The previously approved participation agreement and its burden has been removed due to an exemption from the PRA under 5 CFR 1320.3(h)(1). CMS believes the Participation Agreement to be exempt from the PRA. Therefore, we have not assigned burden to the instrument and will be submitting it as a supplementary document.

Annual Cost to Federal Government: $38,646

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

Agency Contact: Stephan McKenzie 410 786-1943 stephan.mckenzie@cms.hhs.gov

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