Notice2021-14752
Proposed Data Collection Submitted for Public Comment and Recommendations
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
July 12, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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 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.
Full Text
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<title>Federal Register, Volume 86 Issue 130 (Monday, July 12, 2021)</title>
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[Federal Register Volume 86, Number 130 (Monday, July 12, 2021)]
[Notices]
[Pages 36550-36552]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="http://Regulations.gov">Regulations.gov</a>. 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 <a href="http://Regulations.gov">Regulations.gov</a>.
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
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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.
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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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