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Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Notices the efficacy of using administrative insurance and prescription claims billing data to identify and intervene upon persons with HIV who fail to fill antiretroviral ARV prescriptions.
DATES: CDC must receive written comments on or before September 10, 2021.
ADDRESSES: You may submit comments, identified by Docket No. CDC2021
0065 by any of the following methods:
Federal eRulemaking Portal:
Regulations.gov. Follow the instructions for submitting comments.
Mail: Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600
Clifton Road NE, MSD74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to Regulations.gov.
Please note: Submit all comments through the Federal eRulemaking portal regulations.gov or by U.S. mail to the address listed above.
FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS
D74, Atlanta, Georgia 30329; phone:
4046397118; Email: omb@cdc.gov.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 PRA
44 U.S.C. 35013520, Federal agencies must obtain approval from the Office of Management and Budget OMB for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
2. Evaluate the accuracy of the agencys estimate of the burden of the
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proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected;
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses; and 5. Assess information collection costs.
Proposed Project Using Real-time Prescription and Insurance Claims Data to Support the HIV Care ContinuumNewNational Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention NCHHSTP, Centers for Disease Control and Prevention CDC.
Background and Brief Description Use of HIV surveillance data to identify out-of-care persons is one strategy for identifying and re-engaging out-of-care persons, and is called Datato-Care or D2C. Data-to-Care uses laboratory reports i.e., CD4 and HIV
viral load test results received by a health departments HIV surveillance program as markers of HIV care. In the current D2C model, there is a delay in the identification of out-of-care persons due to the time interval between recommended monitoring tests i.e., every three to six months and the subsequent reporting of these tests to surveillance.
Insurance and prescription administrative claims billing data can be used to identify persons who fail to fill antiretroviral ARV prescriptions and who are at risk for falling out of care. Because most ARVs are prescribed as a 30-day supply of medication, prescription claims can be used to identify persons who are not filling ARV
prescriptions on a monthly basis.
Tracking ARV refill data can, therefore, be a more real-time indicator of poor adherence and can act as a harbinger of potential poor retention in care. Using real time insurance and prescription claims data to identify persons who fail to fill ARV prescriptions, and to intervene, could have a significant impact on ARV therapy adherence, viral suppression and potentially on retention in care.
The purpose of the Antiretroviral Improvement among Medicaid Enrollees AIMS study is to develop, implement and evaluate a D2C strategy that uses Medicaid insurance and prescription
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claims data to identify; 1 persons with HIV who have never been prescribed ARV therapy, and 2 persons with HIV
who fail to pick up prescribed ARV
medications in a timely manner, and to target these individuals for adherence interventions.
A validated HIV case identification algorithm will be applied to the Virginia Medicaid database to identify persons with HIV who have either never filled an ARV prescription or have not filled an ARV prescription within >30 to <90
days of the expected fill date.
Deterministic and probabilistic methods will be used to link this list to the Virginia Department of Healths VDH
Care Markers database an extract of the VDH HIV surveillance database.
Individuals that are matched across the two databases indicating that the persons are both enrolled in Medicaid and confirmed HIV positive are eligible for study participation. Additional eligibility criteria include age 1963
years and continuous enrollment in Virginia Medicaid for the preceding 12
months.
Cluster randomization will occur at the healthcare provider level and will be conducted concurrently with the initial potential participant screening.
Providers will be randomized to either the intervention arm or to the usual care arm i.e., no intervention or control arm. Study participants are the patients of the randomized healthcare providers.
Participants in the intervention arm will be delegated to either a patient-level or provider-level intervention, depending on need; participants who are >30 to <90 days late filling their ARV
prescriptions will receive the patientlevel intervention, and participants who have never filled an ARV prescription will be delegated to the provider-level intervention. Participants of the provider-level intervention will not receive direct intervention. Instead, the healthcare providers of these patients provider participants will receive the provider-level intervention.
Potential participants will be contacted by a study Linkage Coordinator to explain the study and obtain consent for participation.
The patient-level intervention has two phases. Phase I is intended for patients who are >30 to <60 days late filling their ARV prescriptions. In Phase I, a Linkage Coordinator will contact participants to discuss the participants adherence barriers. Once the participants adherence barriers are identified, the participant will be referred to appropriate resources to assist them in overcoming their adherence barriers. Phase II is intended for patients who were enrolled
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