[Federal Register Volume 86, Number 199 (Tuesday, October 19, 2021)]
[Notices]
[Pages 57831-57833]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22695]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-22-21GH]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled Using Real-time Prescription and Insurance 
Claims Data to Support the HIV Care Continuum to the Office of 
Management and Budget (OMB) for review and approval. CDC previously 
published a ``Proposed Data Collection Submitted for Public Comment and 
Recommendations'' notice on July 12, 2021 to obtain comments from the 
public and affected agencies. CDC did not receive comments related to 
the previous notice. This notice serves to allow an additional 30 days 
for public and affected agency comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (a) 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;
    (b) Evaluate the accuracy of the agencies estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    (c) Enhance the quality, utility, and clarity of the information to 
be collected;
    (d) 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

[[Page 57832]]

other forms of information technology, e.g., permitting electronic 
submission of responses; and
    (e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570. Comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct 
written comments and/or suggestions regarding the items contained in 
this notice to the Attention: CDC Desk Officer, Office of Management 
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 
395-5806. Provide written comments within 30 days of notice 
publication.

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 (D2C). D2C 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 this information collection, also called 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 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), 
500 controls and 40 provider participants 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

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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.
    OMB approval is requested for three years. Participation is 
voluntary and there are no costs to respondents other than their time. 
CDC requests approval for an estimated 256 annualized burden hours.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
              Respondents                       Form name           respondents   responses  per   response  (in
                                                                                     respondent       hours)
----------------------------------------------------------------------------------------------------------------
Participants of patient-level           Verbal consent--                     153               1           15/60
 intervention.                           participants.
Provider participants.................  Verbal consent--provider              13               1           15/60
                                         participants.
Participants of provider-level          Verbal consent--control               13               1           15/60
 intervention.                           participants (for
                                         participants of
                                         provider-level
                                         intervention).
Control participants..................  Verbal consent--control              167               1           15/60
                                         participants.
Participants of patient-level           HIPPA authorization.....             153               1            5/60
 intervention.
Participants of provider-level          HIPPA authorization.....              13               1            5/60
 intervention.
Control participants..................  HIPPA authorization.....             167               1            5/60
PositiveLinks participants............  PositiveLinks verbal                  33               1           60/60
                                         consent and enrollment.
Participants of patient-level           Phase I interview.......             153               1           30/60
 intervention.
Participants of patient-level           Phase II interview......              33               1           30/60
 intervention.
Advisory Committee to the Virginia      Clinician consultation                 3               4           30/60
 Medication Assistance Program member    guide.
 and other HIV clinical expects.
Provider participants.................  Clinician consultation                13               1           30/60
                                         guide.
Advisory Committee to the Virginia      Post-consultation                      3               4           10/60
 Medication Assistance Program member    questionnaire.
 and other HIV clinical expects.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-22695 Filed 10-18-21; 8:45 am]
BILLING CODE 4163-18-P