Value in Opioid Use Disorder Treatment Demonstration (CMS-10728)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form CMS-10728 Patient Agreement	Form and Instruction	Removed	Available
Form CMS-10728 Participation Agreement	Form and Instruction	Removed	Repair queued
Form CMS-10728 Financial Report	Form and Instruction	Modified	Available
Form CMS-10728 Participant Survey	Form and Instruction	Modified	Available
Form CMS-10728 Participant Survey	Form and Instruction	Modified	Repair queued
Form CMS-10728 Beneficiary Health Survey	Form and Instruction	Modified	Available
Form CMS-10728 Beneficiary Survey	Form and Instruction	Modified	Repair queued
Form CMS-10728 Beneficiary Notification	Form and Instruction	Modified	Available
Form CMS-10728 Beneficiary Notification	Form and Instruction	Modified	Repair queued
Form CMS-10728 Request for Application	Form and Instruction	Modified	Available
Form CMS-10728 OUD Care Team Roster Guidance & Template	Form and Instruction	Modified	Available
Form CMS-10728 Participant's OUD Care Team	Form and Instruction	Modified	Available
Form CMS-10728 Request for Application	Form and Instruction	Modified	Repair queued
CMS-10728_OUD_Supporting Statement - Part A.docx	Supporting Statement A	Uploaded 2023-05-31	Repair queued
Value in Treatment 2022 Amendment No. 1 Sequestration (003).pdf	Supplementary Document	Uploaded 2023-05-31	Repair queued
ViT RFA Attachment 2 prevalence rates.xlsx	Supplementary Document	Uploaded 2020-12-03	Repair queued
ViT_OUD_Diagnosis_Codes.pdf	Supplementary Document	Uploaded 2023-05-31	Repair queued
ViT PA Final clean 3.25.2021.pdf	Supplementary Document	Uploaded 2023-05-31	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
244606	Participation Agreement	Form and Instruction	Removed	Patient Agreement
244606	Participation Agreement	Form and Instruction	Removed
242941	Participant Financial	Form and Instruction	Modified	Financial Report
242941	Participant Financial	Instruction	Modified
242940	Participant Compliance Audit	Instruction	Modified
242939	Participant Survey	Form and Instruction	Modified	Participant Survey
242939	Participant Survey	Form and Instruction	Modified
242934	Beneficiary Survey	Form and Instruction	Modified	Beneficiary Health Survey
242934	Beneficiary Survey	Form and Instruction	Modified
242933	Beneficiary Notification	Form and Instruction	Modified	Beneficiary Notification
242933	Beneficiary Notification	Form and Instruction	Modified
242932	Request for Application	Form and Instruction	Modified	Request for Application
242932	Request for Application	Form and Instruction	Modified	OUD Care Team Roster Guidance & Template
242932	Request for Application	Form and Instruction	Modified	Participant's OUD Care Team
242932	Request for Application	Form and Instruction	Modified

ICR Details

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
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/31/2023
Terms of Clearance: CMS addressed the previous terms of clearance via its SORN.

table that charts list comparision

	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

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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.

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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

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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:
	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

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

table that charts list of burden

IC Title	Form No.	Form Name
Beneficiary Notification	CMS-10728	Beneficiary Notification
Beneficiary Survey	CMS-10728	Beneficiary Health Survey
Participant Compliance Audit
Participant Financial	CMS-10728	Financial Report
Participant Survey	CMS-10728	Participant Survey
Participation Agreement	CMS-10728	Patient Agreement
Request for Application	CMS-10728, CMS-10728, CMS-10728	Participant's OUD Care Team ,   OUD Care Team Roster Guidance & Template ,   Request for Application

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ICR Summary of Burden

table that charts list 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	388	1,100	0	-100	-612	0
Annual Time Burden (Hours)	282	856	0	-200	-374	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: 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.

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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

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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: 05/31/2023

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