Using Real-time Prescription and Insurance Claims Data to Support the HIV Care Continuum

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Post-Consultation Questionnaire (screenshots)	Form and Instruction	New	Available
Post-Consultation Questionnaire	Form and Instruction	New	Repair queued
Clinician Consultation Guide (screenshots)	Form and Instruction	New	Available
Peer-to-Peer Clinician Consultation [Provider Participants]	Form and Instruction	New	Repair queued
Clinician Consultation Guide (screenshots)	Form and Instruction	New	Available
Peer-to-Peer Clinician Consultation [HIV Expert Consultants]	Form and Instruction	New	Repair queued
Referral Script	Form and Instruction	New	Available
Phase II Interview	Form and Instruction	New	Available
Phase II Interview for Participants of Patient-level Intervention	Form and Instruction	New	Repair queued
Referral Script	Form and Instruction	New	Available
Phase I Interview	Form and Instruction	New	Available
Phase I Interview for Participants of Patient-level Intervention	Form and Instruction	New	Repair queued
PositiveLinks Verbal Consent and Enrollment	Form and Instruction	New	Available
PositiveLinks Verbal Consent and Enrollment	Form and Instruction	New	Repair queued
HIPAA Authorization	Form	New	Available
HIPAA Authorization [Control Patient Participants]	Form	New	Repair queued
HIPAA Authorization	Form	New	Available
HIPAA Authorization [Patients of Providers in Provider-level Intervention]	Form	New	Available
HIPAA Authorization	Form	New	Available
HIPAA Authorization [Participants of Patient-level Intervention]	Form	New	Available
Verbal Consent [Control Participants]	Form and Instruction	New	Available
Verbal Consent [Control Patient Participants]	Form and Instruction	New	Repair queued
Verbal Consent [Control Participants]	Form and Instruction	New	Available
Verbal Consent [Patients of Providers in Provider-level Intervention]	Form and Instruction	New	Repair queued
Verbal Consent [Provider Participants]	Form and Instruction	New	Available
Verbal Consent [Providers]	Form and Instruction	New	Repair queued
Verbal Consent [Participants]	Form and Instruction	New	Available
Verbal Consent [Participants of Patient-level Intervention]	Form and Instruction	New	Repair queued
SSA_AIMS_101821.docx	Supporting Statement A	Uploaded 2021-10-18	Repair queued
Att 19_60-Day FRN.pdf	Supplementary Document	Uploaded 2021-10-18	Repair queued
Att 18_Institutional Review Board approval letter.pdf	Supplementary Document	Uploaded 2021-10-18	Repair queued
Att 17b_Certified letter_control participants.docx	Supplementary Document	Uploaded 2021-10-18	Repair queued
Att 17a_Certified letter_participants.docx	Supplementary Document	Uploaded 2021-10-18	Repair queued
Att 16_Privacy Impact Assessment.pdf	Supplementary Document	Uploaded 2021-10-18	Repair queued
Att 15_PositiveLinks data elements.docx	Supplementary Document	Uploaded 2021-10-18	Repair queued
Att 12b_PositiveLinks Program and Service Agreement letter.docx	Supplementary Document	Uploaded 2021-10-18	Repair queued
Att 7c_Contact protocol_control participants.docx	Supplementary Document	Uploaded 2021-10-18	Repair queued
Att 7b_Contact protocol_provider participants.docx	Supplementary Document	Uploaded 2021-10-18	Repair queued
Att 7a_Contact protocol_participants.docx	Supplementary Document	Uploaded 2021-10-18	Repair queued
Att 6b_Study information sheet_provider participants.docx	Supplementary Document	Uploaded 2021-10-18	Repair queued
Att 6a_Study information sheet _providers of participants.docx	Supplementary Document	Uploaded 2021-10-18	Repair queued
Att 5d_Courtesy notification letter to providers of participants.docx	Supplementary Document	Uploaded 2021-10-18	Repair queued
Att 5c_Introductory letter_control participants.docx	Supplementary Document	Uploaded 2021-10-18	Repair queued
Att 5b_Introductory letter_provider participants.docx	Supplementary Document	Uploaded 2021-10-18	Repair queued
Att 5a_Introductory letter_participants.docx	Supplementary Document	Uploaded 2021-10-18	Repair queued
Att 4_Virginia Care Marker Data abstraction.docx	Supplementary Document	Uploaded 2021-10-18	Repair queued
Att 3_Virginia Medicaid data abstraction.docx	Supplementary Document	Uploaded 2021-10-18	Repair queued
Att 2_Technical Appendix_09292021.docx	Supplementary Document	Uploaded 2021-10-18	Repair queued
Att 1_Authorizing legislation.pdf	Supplementary Document	Uploaded 2021-10-18	Repair queued
SSB_AIMS_092921.docx	Supporting Statement B	Uploaded 2021-10-15	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
249805	Post-Consultation Questionnaire	Other-WORD version of content to facilitate review	New
249805	Post-Consultation Questionnaire	Form and Instruction	New	Post-Consultation Questionnaire (screenshots)
249805	Post-Consultation Questionnaire	Form and Instruction	New
249803	Peer-to-Peer Clinician Consultation [Provider Participants]	Other-WORD version of content to facilitate review	New
249803	Peer-to-Peer Clinician Consultation [Provider Participants]	Form and Instruction	New	Clinician Consultation Guide (screenshots)
249803	Peer-to-Peer Clinician Consultation [Provider Participants]	Form and Instruction	New
249797	Peer-to-Peer Clinician Consultation [HIV Expert Consultants]	Other-WORD version of content to facilitate review	New
249797	Peer-to-Peer Clinician Consultation [HIV Expert Consultants]	Form and Instruction	New	Clinician Consultation Guide (screenshots)
249797	Peer-to-Peer Clinician Consultation [HIV Expert Consultants]	Form and Instruction	New
249796	Phase II Interview for Participants of Patient-level Intervention	Form and Instruction	New	Referral Script
249796	Phase II Interview for Participants of Patient-level Intervention	Form and Instruction	New	Phase II Interview
249796	Phase II Interview for Participants of Patient-level Intervention	Form and Instruction	New
249793	Phase I Interview for Participants of Patient-level Intervention	Form and Instruction	New	Referral Script
249793	Phase I Interview for Participants of Patient-level Intervention	Form and Instruction	New	Phase I Interview
249793	Phase I Interview for Participants of Patient-level Intervention	Form and Instruction	New
249772	PositiveLinks Verbal Consent and Enrollment	Form and Instruction	New	PositiveLinks Verbal Consent and Enrollment
249772	PositiveLinks Verbal Consent and Enrollment	Form and Instruction	New
249771	HIPAA Authorization [Control Patient Participants]	Form	New	HIPAA Authorization
249771	HIPAA Authorization [Control Patient Participants]	Form	New
249770	HIPAA Authorization [Patients of Providers in Provider-level Intervention]	Form	New	HIPAA Authorization
249770	HIPAA Authorization [Patients of Providers in Provider-level Intervention]	Form	New
249769	HIPAA Authorization [Participants of Patient-level Intervention]	Form	New	HIPAA Authorization
249769	HIPAA Authorization [Participants of Patient-level Intervention]	Form	New
249768	Verbal Consent [Control Patient Participants]	Form and Instruction	New	Verbal Consent [Control Participants]
249768	Verbal Consent [Control Patient Participants]	Form and Instruction	New
249766	Verbal Consent [Patients of Providers in Provider-level Intervention]	Form and Instruction	New	Verbal Consent [Control Participants]
249766	Verbal Consent [Patients of Providers in Provider-level Intervention]	Form and Instruction	New
249765	Verbal Consent [Providers]	Form and Instruction	New	Verbal Consent [Provider Participants]
249765	Verbal Consent [Providers]	Form and Instruction	New
249764	Verbal Consent [Participants of Patient-level Intervention]	Form and Instruction	New	Verbal Consent [Participants]
249764	Verbal Consent [Participants of Patient-level Intervention]	Form and Instruction	New

ICR Details

OMB Control No: 0920-1361	ICR Reference No: 202109-0920-005
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-21GH
Title: Using Real-time Prescription and Insurance Claims Data to Support the HIV Care Continuum
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 without change	Conclusion Date: 02/25/2022
Retrieve Notice of Action (NOA)	Date Received in OIRA: 10/19/2021
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2025	36 Months From Approved
Responses	935	0	0
Time Burden (Hours)	256	0	0
Cost Burden (Dollars)	6,908	0	0

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Abstract: This information collection request supports the "Antiretroviral Improvement Among Medicaid Enrollees" (AIMS) study. The study will evaluate the efficacy of a Data-to-Care strategy that uses timely administrative insurance and prescription claims (billing) data to identify and intervene upon persons with HIV who fail to fill antiretroviral (ARV) prescriptions, before those individuals are lost to care. The intervention includes educational and referral resources for persons with HIV and health care providers.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service Act
  

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:
	86 FR 36550	07/12/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 57831	10/19/2021
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 13

table that charts list of burden

IC Title	Form No.	Form Name
HIPAA Authorization [Control Patient Participants]	n/a	HIPAA Authorization
HIPAA Authorization [Participants of Patient-level Intervention]	n/a	HIPAA Authorization
HIPAA Authorization [Patients of Providers in Provider-level Intervention]	n/a	HIPAA Authorization
Peer-to-Peer Clinician Consultation [HIV Expert Consultants]	n/a	Clinician Consultation Guide (screenshots)
Peer-to-Peer Clinician Consultation [Provider Participants]	n/a	Clinician Consultation Guide (screenshots)
Phase I Interview for Participants of Patient-level Intervention	n/a, n/a	Phase I Interview ,   Referral Script
Phase II Interview for Participants of Patient-level Intervention	n/a, n/a	Phase II Interview ,   Referral Script
PositiveLinks Verbal Consent and Enrollment	n/a	PositiveLinks Verbal Consent and Enrollment
Post-Consultation Questionnaire	n/a	Post-Consultation Questionnaire (screenshots)
Verbal Consent [Control Patient Participants]	n/a	Verbal Consent [Control Participants]
Verbal Consent [Participants of Patient-level Intervention]	n/a	Verbal Consent [Participants]
Verbal Consent [Patients of Providers in Provider-level Intervention]	n/a	Verbal Consent [Control Participants]
Verbal Consent [Providers]	n/a	Verbal Consent [Provider Participants]

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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	935	0	0	935	0	0
Annual Time Burden (Hours)	256	0	0	256	0	0
Annual Cost Burden (Dollars)	6,908	0	0	6,908	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: This is a new, one-time information collection request.

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Annual Cost to Federal Government: $709,235

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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.     Yes

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: 10/19/2021

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