[Federal Register Volume 85, Number 99 (Thursday, May 21, 2020)]
[Notices]
[Pages 30958-30960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10999]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-20-20NT; Docket No. CDC-2020-0054]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled Using Real-time Prescription and 
Insurance Claims Data to Support the HIV Care Continuum which will 
collect data to evaluate 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 July 20, 2020.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0054 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, MS-D74, 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: 404-639-7570; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), 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 agency's estimate of the burden of 
the 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; and
    4. Minimize the burden of the collection of information on those 
who

[[Page 30959]]

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.
    5. Assess information collection costs.

Proposed Project

    Using Real-time Prescription and Insurance Claims Data to Support 
the HIV Care Continuum--New--National 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 Data-to-Care or ``D2C.'' Data-to-Care uses laboratory reports 
(i.e., CD4 and HIV viral load test results) received by a health 
department's 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 becoming 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 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 Virginia Department of Health's (VDH) Care Markers (an extract of 
the VDH HIV surveillance database) 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 19-64 years 
and continuous enrollment in Virginia Medicaid for the preceding 12 
months.
    Once identified, individuals will be randomized to receive either 
an intervention or usual care. Participants in the intervention arm 
will be assigned to receive either a provider-level intervention or a 
patient-level intervention, depending on need; providers of study 
eligible participants who have never been prescribed ARV therapy (ART) 
will receive a provider-level intervention and participants who are >30 
to <90 days late filling their ARV prescriptions will receive a 
patient-level intervention. Potential participants will be contacted by 
a VDH Linkage Coordinator or Study Coordinator to explain the study and 
obtain consent for participation.
    The provider-level intervention will consist of a peer-to-peer 
clinician consultation delivered by members of Virginia Department of 
Health's AIDS Drug Assistance Program (ADAP) Advisory Committee. The 
peer-to-peer clinician consultations will involve introduction or 
reinforcement of HIV clinical guidelines for ART initiation, strategies 
to optimize ART adherence, and resources for supporting adherence for 
people with HIV. The consultation will be tailored to the needs of the 
provider.
    The patient-level intervention has two phases. In Phase I, a 
Linkage Coordinator will contact participants to discuss the 
participants' adherence barriers. Once the participant's adherence 
barriers are identified, the participant will be referred to 
appropriate resources to assist them in overcoming their adherence 
barrier(s). Phase II is intended for patients who were enrolled in 
Phase I but who failed to fill their ARV prescriptions in the 
subsequent 30 days of the Phase I consultation, and for participants 
who are >60 to <90 days late at the time the participant was determined 
to be study eligible. In Phase II, the Linkage Coordinator will lead a 
similar consultation as in Phase I but will probe for more complex 
adherence barriers (e.g., mental health concerns) and referrals will be 
made accordingly. The participant will also be offered PositiveLinks, 
an evidence-informed mobile application (``app'') which is designed to 
support ART adherence and retention in care. PositiveLinks provides 
daily queries of stress, mood, and medication adherence; weekly quizzes 
on general and HIV-specific understanding; appointment and medication 
reminders, curated resources, a community message board, direct 
messaging with the Linkage Coordinator, and contact information for 
participants' providers.
    All analyses will be conducted at the patient level. Persons within 
the intervention and control arms will be followed for 12 months to 
compare the primary study outcome of HIV viral suppression (HIV RNA < 
200 copies/mL).
    CDC requests OMB approval to collect standardized information, from 
500 AIMS study participants (including 460 patients and 40 providers) 
and 500 controls over the three year project period. Secondary data 
will be abstracted from the Virginia Medicaid and Virginia Department 
of Health Care Marker databases to determine study eligibility, to 
conduct the patient- and provider-level interventions, and to determine 
study outcomes. During the patient-level intervention data will be 
collected on participants' adherence barriers; this information will be 
used to refer participants to appropriate resources to assist their 
adherence to ART. During the provider-level intervention data will be 
collected to inform the peer-to-peer clinician consultation.

[[Page 30960]]



                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
          Respondents               Form name       respondents    responses per   response  (in       hours
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Linkage Coordinator...........  Verbal consent               460               1           15/60             115
                                 (patient).
Study Coordinator.............  Verbal consent                40               1           15/60              10
                                 (provider).
Linkage Coordinator...........  PositiveLinks                100               1           60/60             100
                                 Program and
                                 Services
                                 Agreement.
VCU Data Manager..............  Medicaid data                  1              12           60/60              12
                                 abstraction.
VDH Surveillance                Care Marker data               1              12           60/60              12
 Epidemiologist.                 abstraction.
Linkage Coordinator...........  Phase I                      460               1           30/60             230
                                 interview and
                                 Phase I data
                                 elements.
Linkage Coordinator...........  Phase II                     100               1           30/60              50
                                 interview and
                                 Phase II data
                                 elements.
Linkage Coordinator...........  PositiveLinks                  1               4           15/60               1
                                 data
                                 abstraction.
ADAP Advisory Committee member  Clinician                     40               1           30/60              20
                                 consultation
                                 and Clinician
                                 consultation
                                 data elements.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             550
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2020-10999 Filed 5-20-20; 8:45 am]
 BILLING CODE 4163-18-P