[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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