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

Forms and Documents

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

IC Document Collections

IC ID	Document Title	Status
249805	Post-Consultation Questionnaire Form and Instruction	New
249803	Peer-to-Peer Clinician Consultation [Provider Participants] Form and Instruction	New
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
249793	Phase I Interview for Participants of Patient-level Intervention Form and Instruction	New
249772	PositiveLinks Verbal Consent and Enrollment Form and Instruction	New
249771	HIPAA Authorization [Control Patient Participants] Form	New
249770	HIPAA Authorization [Patients of Providers in Provider-level Intervention] Form	New
249769	HIPAA Authorization [Participants of Patient-level Intervention] Form	New
249768	Verbal Consent [Control Patient Participants] Form and Instruction	New
249766	Verbal Consent [Patients of Providers in Provider-level Intervention] Form and Instruction	New
249765	Verbal Consent [Providers] Form and Instruction	New
249764	Verbal Consent [Participants of Patient-level Intervention] Form and Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 202109-0920-005
Status: Received in OIRA	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	Date Submitted to OIRA: 10/19/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	935	0
Time Burden (Hours)	256	0
Cost Burden (Dollars)	6,908	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

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

	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	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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