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

Forms and Documents

Document Name	Status
Form CMS-10728 Participation Agreement Form and Instruction	New
Form CMS-10728 Participant Financial Form and Instruction	New
Form CMS-10728 Participant Survey Form and Instruction	New
Form CMS-10728 Beneficiary Survey Form and Instruction	New
Form CMS-10728 Beneficiary Notification Form and Instruction	New
Form CMS-10728 Request for Application Form and Instruction	New
ViT RFA Attachment 2 prevalence rates.xlsx Supplementary Document	2020-12-03
ViT PRA Comments_Response.docx Supplementary Document	2020-09-11
ViT RFA Appendix B_02212020_508.pdf Supplementary Document	2020-09-11
ViT PA Final clean 10.15.2020.docx Supplementary Document	2020-10-19
RFA_Value in Treatment FINAL.docx Supplementary Document	2020-12-04
PRA_OUD_Supporting Statement - Part A_CLEAN_ - Passback3.docx Supporting Statement A	2020-12-04

IC Document Collections

IC ID	Document Title	Status
244606	Participation Agreement Form and Instruction	New
242941	Participant Financial Form and Instruction	New
242940	Participant Compliance Audit Instruction	New
242939	Participant Survey Form and Instruction	New
242934	Beneficiary Survey Form and Instruction	New
242933	Beneficiary Notification Form and Instruction	New
242932	Request for Application Form and Instruction	New

ICR Details

OMB Control No: 0938-1388	ICR Reference No: 202007-0938-012
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No: CMMI
Title: Value in Opioid Use Disorder Treatment Demonstration (CMS-10728)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 12/04/2020
	Date Received in OIRA: 09/14/2020
Terms of Clearance: Approval is provided on the basis that the program work further with the CMS Privacy Officer to refine the information provided to beneficiaries regarding the sharing of the their health data. Any changes made to the information provided should be submitted to OIRA as a non-substantive change.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2023	36 Months From Approved
Responses	1,100	0	0
Time Burden (Hours)	856	0	0
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): US Code: 42 USC 1866F Name of Law: Opioid Use Disorder Treatment Demonstration Program
   PL: Pub.L. 115 - 271 6042 Name of Law: Opioid Use Disorder Treatment Demonstration Program
  

Citations for New Statutory Requirements: PL: Pub.L. 115 - 271 6042 Name of Law: Opioid Use Disorder Treatment Demonstration Program

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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:
	85 FR 32397	05/29/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 56227	09/11/2020
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 7

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

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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	1,100	0	1,100	0	0	0
Annual Time Burden (Hours)	856	0	856	0	0	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:

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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: 09/14/2020

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