[Federal Register Volume 86, Number 130 (Monday, July 12, 2021)]
[Notices]
[Pages 36550-36552]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14752]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-21-21GH; Docket No. CDC-2021-0065]


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. This proposed 
collection will collect data to evaluate

[[Page 36551]]

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. CDC-2021-
0065 by any of the following methods:
    <bullet> Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
    <bullet> 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: 404-639-7118; Email: 
<a href="/cdn-cgi/l/email-protection#77181a153714131459101801"><span class="__cf_email__" data-cfemail="ea858788aa898e89c48d859c">[email protected]</span></a>.

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;
    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 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 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 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 Health's (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 19-63 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 prescription(s) will receive the patient-level 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 
prescription(s). 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

[[Page 36552]]

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 an evidence-
informed mobile application (``app'') which is designed to support ART 
adherence and retention in care.
    The provider-level intervention will consist of a peer-to-peer 
clinician consultation delivered by clinicians from the Virginia 
Department of Health's Advisory Committee to the Virginia Medication 
Assistance Program or by another HIV clinical expert. 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 
participant.
    All analyses will be conducted at the patient level. Persons within 
the intervention arm will be followed prospectively for 12 months. At 
the end of the intervention arm follow-up period, persons within the 
usual care arm will be followed retrospectively for 12 months. The 
primary study outcome of HIV viral suppression (HIV RNA <200 copies/mL) 
will be compared between study arms.
    CDC requests OMB approval to collect standardized information from 
500 AIMS study participants (460 participants of the patient-level 
intervention and 40 participants of the provider-level intervention) 
and 500 controls over the three-year project period. Secondary data 
will be abstracted from the Virginia Medicaid and Virginia Care Markers 
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.
    CDC requests OMB approval for an estimated 687 burden hours 
annually. There are no costs to respondents other than their time to 
participate.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Participants..................  Verbal consent--             460               1           15/60             115
                                 participants.
Provider participants.........  Verbal consent--              40               1           15/60              10
                                 provider
                                 participants.
Participants..................  Verbal consent--              40               1           15/60              10
                                 control
                                 participants
                                 (for
                                 participants of
                                 provider-level
                                 intervention).
Control participants..........  Verbal consent--             500               1           15/60             125
                                 control
                                 participants.
PositiveLinks participants....  PositiveLinks                100               1           60/60             100
                                 enrollment.
Participants..................  Phase I                      460               1           30/60             230
                                 interview.
Participants..................  Phase II                     100               1           30/60              50
                                 interview.
Advisory Committee to the       Clinician                     10               4           30/60              20
 Virginia Medication             consultation.
 Assistance Program member and
 other HIV clinical expects.
Provider participants.........  Clinician                     40               1           30/60              20
                                 consultation.
Advisory Committee to the       Post-                         10               4           10/60               7
 Virginia Medication             consultation
 Assistance Program member and   questionnaire.
 other HIV clinical expects.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             687
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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. 2021-14752 Filed 7-9-21; 8:45 am]
BILLING CODE 4163-18-P


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