Notice2021-22695
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 19, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 86 Issue 199 (Tuesday, October 19, 2021)</title>
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[Federal Register Volume 86, Number 199 (Tuesday, October 19, 2021)]
[Notices]
[Pages 57831-57833]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
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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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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
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Average
Number of Number of burden per
Respondents Form name respondents responses per response (in
respondent hours)
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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.
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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. 2021-22695 Filed 10-18-21; 8:45 am]
BILLING CODE 4163-18-P
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