Notice of Privacy Act of 1974; System of Records, 3999-4002 [2023-01145]
Download as PDF
<![CDATA[
3999
Federal Register / Vol. 88, No. 14 / Monday, January 23, 2023 / Notices
ESTIMATED ANNUALIZED BURDEN TABLE—Continued
Number of
responses per
respondent
Average
burden hours
per response
[1]
Total burden
hours
Type of respondent
164.520 .........................
Notice of Privacy Practices for Protected Health
Information (health plans—periodic distribution
of NPPs by paper mail) [13], [18].
Notice of Privacy Practices for Protected Health
Information (health plans—periodic distribution
of NPPs by electronic mail) [19].
Notice of Privacy Practices for Protected Health
Information (health care providers—dissemination and acknowledgement) [14].
Rights to Request Privacy Protection for Protected Health Information [15].
Access of Individuals to Protected Health Information (disclosures) [16].
Amendment of Protected Health Information (requests).
Amendment of Protected Health Information (denials).
Accounting for Disclosures of Protected Health
Information [17].
100,000,000
1
0.004166667
416,667
100,000,000
1
0.002783333
278,333
613,000,000
1
0.05
30,650,000
20,000
1
0.05
1,000
200,000
1
0.05
10,000
150,000
1
0.083333333
12,500
50,000
1
0.083333333
4,167
5,000
1
0.05
250
..............................................................................
........................
2,070
........................
921,158,940
164.520 .........................
164.520 .........................
164.522 .........................
164.524 .........................
164.526 .........................
164.526 .........................
164.528 .........................
Total .......................
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2023–01196 Filed 1–20–23; 8:45 am]
BILLING CODE 4153–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice of Privacy Act of 1974; System
of Records
Office of Infectious Disease and
HIV/AIDS Policy, Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice of a new system of
records.
AGENCY:
In accordance with the
Privacy Act, the Department of Health
and Human Services (HHS) is
establishing a new system of records to
be maintained by the Office of
Infectious Disease and HIV/AIDS Policy
within the Office of the Assistant
Secretary for Health (OASH/OIDP),
System No. 09–90–2101 ‘‘HIV
Prevention Medication Distribution
Records.’’ The new system of records
will consist of records about individual
patients who participate in the Ending
the HIV Epidemic—Pre-Exposure
Prophylaxis Implementation and
Distribution Services Program (PrEP
Program), which will provide donated
HIV prevention medication to patients
in the United States who are at
substantial risk of acquiring the human
immunodeficiency virus (HIV).
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
respondents
Section
VerDate Sep<11>2014
16:44 Jan 20, 2023
Jkt 259001
In accordance with 5 U.S.C.
552a(e)(4) and (11), this notice is
effective upon publication, subject to a
30-day period in which to comment on
the routine uses, described below.
Please submit any comments by
February 22, 2023.
ADDRESSES: The public should submit
comments on the new system of records
by email to ann.abercrombie@hhs.gov.
FOR FURTHER INFORMATION CONTACT:
General questions about the system of
records may be submitted to Ann
Abercrombie, OASH/OIDP at (202) 401–
9588, or ann.abercrombie@hhs.gov.
SUPPLEMENTARY INFORMATION: Within the
U.S. Department of Health and Human
Services (HHS), the Office of the
Assistant Secretary for Health (OASH)
leads development of agency-wide
public health policy recommendations
and oversees core public health offices,
including the Office of the Surgeon
General and the U.S. Public Health
Service Commissioned Corps, as well as
10 regional health offices across the
nation and 10 presidential and
secretarial advisory committees. The
mission of the Office of Infectious
Disease and HIV/AIDS Policy (OIDP) is
to provide strategic leadership and
management, while encouraging
collaboration, coordination, and
innovation among federal agencies and
stakeholders to reduce the burden of
infectious diseases, including the
human immunodeficiency virus (HIV).
The initiative to End the HIV
Epidemic in the U.S. is part of a
national HIV prevention and control
DATES:
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
effort to reduce the number of new HIV
infections by 75% in five years and 90%
in 10 years. A key component of the
initiative is expanding access to HIV
prevention medication for patients who
are at substantial risk of acquiring the
disease. Pursuant to a donation
agreement executed May 8, 2019, a drug
manufacturer, Gilead Sciences, Inc.
(Gilead), donated certain HIV
prevention medication (emtricitabine/
tenofovir disoproxil fumarate and
emtricitabine/tenofovir alafenamide
tablets, collectively referred to as
‘‘Product’’) to HHS for distribution
through the Ending the HIV Epidemic—
Pre-Exposure Prophylaxis (PrEP)
Implementation and Distribution
Services Program (PrEP Program), which
will be administered by OASH/OIDP
subject to the terms of the donation
agreement between Gilead and HHS.
Under the terms of the donation
agreement, Gilead will donate Product
for up to 200,000 individuals each year
up to end of 2030 or earlier. The PrEP
Program, through a contractor engaged
by OASH/OIDP, will issue an
enrollment card or electronic
enrollment confirmation, containing a
unique identification number, to each
qualified eligible patient in the United
States who applies to the program (up
to 200,000 individuals per year). This
will enable the patient to obtain the
Product at no cost, either in person or
by mail, from a participating pharmacy.
The contractor will operate a mail order
pharmacy to acquire the Product from
Gilead and dispense it to patients who
elect to receive the Product by mail. The
E:\FR\FM\23JAN1.SGM
23JAN1
4000
Federal Register / Vol. 88, No. 14 / Monday, January 23, 2023 / Notices
contractor will also engage a
subcontractor to serve as a claims
processor to verify the validity of
enrollment identification numbers for
pharmacies before pharmacies dispense
the Product, and to reimburse the
pharmacies’ acquisition costs and taxes.
All prescription and shipping costs will
be 100% covered by OIDP and the
Gilead donation. However, costs that
patients incur for clinic visits and lab
tests required to remain eligible for the
program are not covered by the program.
The mail-order pharmacy and other
pharmacies that wish to participate in
the program must sign an agreement
with HHS agreeing that they will donate
their services (agreeing to be reimbursed
only for wholesale acquisition cost and
taxes for the Product they dispense).
Participating pharmacies also sign an
addendum with the claims processor
acknowledging that they will receive
reimbursement for wholesale
acquisition cost and taxes only, with no
dispensing or other fees. The list of
participating pharmacies is available on
this website https://www.hiv.gov/
federal-response/ending-the-hivepidemic/prep-pharmacies.
The claims processor (subcontractor)
will have access to enrollment
identification numbers and the dates the
numbers are valid (not other
information about patients). The
contractor will collect and maintain all
records needed to determine patients’
initial and continued eligibility for the
Program and to operate the mail-order
pharmacy. The contractor will, for
example, obtain twice yearly
confirmations of the patient’s continued
eligibility from the patient and the
patient’s prescribing health care
provider; and, if the patient elects mail
order, the contractor will notify the
provider to send the prescription to the
mail-order pharmacy to be filled. The
mail-order pharmacy will confirm the
patient’s shipping information and
current eligibility for the program, using
the patient’s enrollment identification
number.
Dated: December 6, 2022.
Rucia A. Abercrombie,
Lead Management Analyst, OIDP.
SYSTEM NAME AND NUMBER:
khammond on DSKJM1Z7X2PROD with NOTICES
HIV Prevention Medication
Distribution Records, 09–90–2101.
SECURITY CLASSIFICATION:
Unclassified.
SYSTEM LOCATION:
The address of the agency component
responsible for the system of records is
the Office of Infectious Disease and
HIV/AIDS Policy (OASH/OIDP), U.S.
VerDate Sep<11>2014
16:44 Jan 20, 2023
Jkt 259001
Department of Health & Human
Services, 330 C St. SW—Suite L100,
Washington, DC 20024. The records will
be housed in a contractor-owned
information technology (IT) system.
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:
SYSTEM MANAGER(S):
CATEGORIES OF RECORDS IN THE SYSTEM:
Director, Office of Infectious Disease
and HIV/AIDS Policy (OASH/OIDP),
Department of Health & Human
Services, 330 C St. SW–Suite L100,
Washington, DC 20201, (202) 795–7697.
The records will consist of
application records, enrolled patient
records, and reimbursement records.
• Application records will include
information needed to identify a patient
and verify the patient’s initial eligibility
to be enrolled in the Program, to
include: patient name, date of birth,
location, and the last four digits of the
patient’s Social Security Number; name
and address of prescribing practitioner
and practice location; the patient’s
certification that the patient is not
covered by a health insurance plan or
policy that covers outpatient
prescription drugs; and the patient’s
consent to information sharing between
OASH/OIDP, its contractor, the Product
manufacturer, and the patient’s
prescribing health care provider. A
patient (or the patient’s health care
provider) can submit an application to
the program through the Program’s
online portal or call center hub.
Demographic information (race,
ethnicity, gender identity, and sex
assigned at birth) will be included in
both application records and enrolled
patient records, for statistical purposes
only, to use in government analyses of
the data at an aggregate level.
• Enrolled patient records will
include the above application
information; a unique identifier
assigned to the patient by the OASH/
OIDP contractor (included on the
patient’s enrollment card or enrollment
confirmation); twice yearly
confirmations of the patient’s continued
eligibility (e.g., negative HIV status
based on quarterly HIV tests) from the
patient’s prescribing health care
provider; amount of Product dispensed
to the patient, reported by the
participating pharmacy; and periodic recertification(s) from the patient attesting
that the patient is not covered by a
health insurance plan or policy that
covers outpatient prescription drugs.
The records will also indicate whether
the patient elected to receive Product by
mail or was issued an enrollment card
to use to obtain the Product from the
participating pharmacy’s customary
retail inventory.
• The claims processor will use the
enrollment identification number
provided by a participating pharmacy to
verify patient eligibility in the program
and to generate a claim number used to
reimburse the pharmacy’s wholesale
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Authorization to collect and maintain
the records is provided under sections
301, 1702, and 1703 of the Public Health
Service Act (42 U.S.C. 241, 300u–1, and
300u–2).
PURPOSE(S) OF THE SYSTEM:
The records in this system of records
will be used to administer the PreExposure Prophylaxis (PrEP)
Implementation and Distribution
Services Program (PrEP Program, or
Program), the goal of which is to
distribute donated HIV prevention
medication (Product) appropriately to
qualifying patients in the United States
who are at high risk of acquiring HIV,
in order to reduce transmission of HIV.
To administer the Program, OASH/
OIDP, through a contractor, will use the
records for these specific purposes:
• To determine if patients who apply
for enrollment in the Program are
eligible to receive the Product under the
terms of the donation agreement
between HHS and the drug
manufacturer, Gilead Sciences, Inc.
(Gilead);
• To enroll qualified eligible patients
in the Program and issue an enrollment
card or confirmation containing a
unique enrollment identification
number to each enrolled patient, and,
thereafter, to confirm each patient’s
continued eligibility to remain enrolled
in the Program;
• To verify the validity of enrollment
identification numbers, for Product
dispensing and cost reimbursement
purposes.
• To reimburse participating
pharmacies’ wholesale acquisition cost
and taxes, for the Product they dispense
to patients;
• To monitor and audit the Program
to prevent, detect, and address any
program violations, errors, fraud, and
improper distribution of benefits, to
ensure the integrity of the Program; and
• To compile statistics for reports and
to conduct research to evaluate the
effectiveness of the Program.
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
The records will be about patients
who apply for Product through the PrEP
Program.
E:\FR\FM\23JAN1.SGM
23JAN1
Federal Register / Vol. 88, No. 14 / Monday, January 23, 2023 / Notices
acquisition cost and taxes for the
Product dispensed.
RECORD SOURCE CATEGORIES:
Information in the patient’s
application records and enrolled patient
records will be obtained directly from
the patient or the patient’s prescribing
health care provider. The OASH/OIDP
contractor will assign the unique
enrollment identification number to the
patient upon enrollment.
khammond on DSKJM1Z7X2PROD with NOTICES
ROUTINE USES OF RECORDS MAINTAINED IN THE
SYSTEM, INCLUDING CATEGORIES OF USERS AND
PURPOSES OF SUCH USES:
In addition to other disclosures that
may be made without the patient’s
prior, written consent which are
authorized directly in the Privacy Act at
5 U.S.C. 552a(b)(1)–(b)(2) and (b)(4)–
(11), HHS may disclose information
about a patient from this system of
records to parties outside the agency
pursuant to these routine uses.
1. Records may be disclosed to agency
contractors, consultants, or others who
have been engaged by the agency to
assist in accomplishment of an HHS
function relating to the purposes of this
system of records and who need to have
access to the records in order to assist
HHS. Note that this routine use will
authorize any such disclosures which
are not adequately covered by the
patient’s consent provided on or with
the enrollment application. Any
contractor will be required to comply
with the requirements of the Privacy
Act.
2. Records may be disclosed to a
patient’s prescribing healthcare provider
to verify the patient’s initial, or
continued, eligibility for enrollment.
Note that this routine use will authorize
any such disclosures which are not
adequately covered by the patient’s
consent on or with the enrollment
application.
3. Records may be disclosed to Gilead
Sciences, Inc., to ensure individuals are
not actively enrolling in both Gilead’s
Advancing Access program and HHS’
Ready, Set, PrEP program
simultaneously. Note that this routine
use will authorize any such disclosures
which are not adequately covered by the
patient’s consent on or with the
enrollment application.
4. Information may be disclosed to the
U.S. Department of Justice (DOJ) or to a
court or other tribunal in litigation or
other proceedings, when the agency or
any component thereof, or any
employee of the agency in his or her
official capacity, or any employee of the
agency in his or her individual capacity
where DOJ has agreed to represent the
employee, or the United State
VerDate Sep<11>2014
16:44 Jan 20, 2023
Jkt 259001
Government is a party to the
proceedings or has an interest in such
proceedings and, by careful review,
HHS determines that the records are
both relevant and necessary to the
proceedings.
5. Records may be disclosed to a
congressional office from the record of
an individual in response to a written
inquiry from the congressional office
made at the written request of that
individual.
6. Records may be disclosed to
representatives of the National Archives
and Records Administration (NARA)
during records management inspections
conducted pursuant to 44 U.S.C. 2904
and 2906.
7. Records may be disclosed to
appropriate agencies, entities, and
persons when (1) HHS suspects or has
confirmed that there has been a breach
of the system of records, (2) HHS has
determined that as a result of the
suspected or confirmed breach there is
a risk of harm to individuals, HHS
(including its information systems,
programs, and operations), the federal
government, or national security, and
(3) the disclosure made to such
agencies, entities, and persons is
reasonably necessary to assist in
connection with HHS’s efforts to
respond to the suspected or confirmed
breach or to prevent, minimize, or
remedy such harm.
8. Records may be disclosed to
another federal agency or federal entity,
when HHS determines that information
from this system of records is
reasonably necessary to assist the
recipient agency or entity in (1)
responding to a suspected or confirmed
breach or (2) preventing, minimizing, or
remedying the risk of harm to
individuals, the recipient agency or
entity (including its information
systems, programs, and operations), the
federal government, or national security,
resulting from a suspected or confirmed
breach.
POLICIES AND PRACTICES FOR STORAGE OF
RECORDS:
The records will be stored on
electronic media.
POLICIES AND PRACTICES FOR RETRIEVAL OF
RECORDS:
Records will be retrieved by the
patient’s unique enrollment
identification number.
POLICIES AND PRACTICES FOR RETENTION AND
DISPOSAL OF RECORDS:
OASH is developing a disposition
schedule for the records and plans to
propose a retention period of
approximately 10 years for the records.
Until the schedule has been submitted
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
4001
to and approved by the National
Archives and Records Administration
(NARA), the records will be retained
indefinitely.
ADMINISTRATIVE, TECHNICAL, AND PHYSICAL
SAFEGUARDS:
The records will be safeguarded in
accordance with applicable laws, rules
and policies, including the pertinent
National Institutes of Standards and
Technology (NIST) publications and
OMB Circular A–130, Managing
Information as a Strategic Resource.
Records will be protected from
unauthorized access through
appropriate administrative, physical,
and technical safeguards. Safeguards
will conform to the HHS Information
Security and Privacy Program, https://
www.hhs.gov/ocio/securityprivacy/.
The safeguards will include
protecting the facilities where records
are stored or accessed with security
guards, badges and cameras; limiting
access to electronic databases to
authorized users based on roles and the
principle of least privilege and either
two-factor authentication or user name
and password; using a secured operating
system protected by encryption,
firewalls, and intrusion detection
systems; using an SSL connection for
secure encrypted transmissions;
requiring encryption for records stored
on removable media; and training
personnel in Privacy Act and
information security requirements.
Records that are eligible for destruction
will be disposed of using secure
destruction methods prescribed by NIST
SP 800–88.
RECORD ACCESS PROCEDURES:
An individual seeking access to
records about him or her in this system
of records must submit a written access
request to the System Manager (see
above ‘‘System Manager’’ section). The
request must contain the requester’s full
name, address, and signature. The
request should also contain the
requester’s contact information and
sufficient identifying particulars (such
as, the unique identifier from the
individual’s enrollment card or
enrollment confirmation) to enable HHS
to locate the requested records. To
verify the requester’s identity, the
signature must be notarized or the
request must include the requester’s
written certification that the requester is
the individual who the requester claims
to be and that the requester understands
that the knowing and willful request for
or acquisition of records pertaining to
an individual under false pretenses is a
criminal offense subject to a fine of up
to $5,000. Requesters may also ask for
E:\FR\FM\23JAN1.SGM
23JAN1
4002
Federal Register / Vol. 88, No. 14 / Monday, January 23, 2023 / Notices
an accounting of disclosures that have
been made of records about them, if any.
CONTESTING RECORD PROCEDURES:
An individual seeking to amend a
record about him or her in this system
of records must submit a written
amendment request to the System
Manager (see above ‘‘System Manager’’
section), containing the same
information required for an access
request and including verification of the
requester’s identity in the same manner
required for an access request. In
addition, the request must reasonably
identify the record and specify the
information being contested, the
corrective action sought, and the
reasons for requesting the correction;
and should include supporting
information, showing how the record is
inaccurate, incomplete, untimely, or
irrelevant.
NOTIFICATION PROCEDURES:
An individual who wishes to know if
this system of records contains records
about that individual must submit a
written notification request to the
System Manager (see above ‘‘System
Manager’’ section). The request must
contain the same information required
for an access request and and must
include verification of the requester’s
identity in the same manner required for
an access request.
EXEMPTIONS PROMULGATED FOR THE SYSTEM:
None.
HISTORY:
None.
[FR Doc. 2023–01145 Filed 1–20–23; 8:45 am]
BILLING CODE 4150–43–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
khammond on DSKJM1Z7X2PROD with NOTICES
4-in-1 Grant Program—Urban Indian
Health
Announcement Type: New and
Competing Continuation.
Funding Announcement Number:
HHS–2023–IHS–UIHP2–0001.
Assistance Listing (Catalog of Federal
Domestic Assistance or CFDA) Number:
93.193.
Key Dates
Application Deadline Date: February
21, 2023.
Earliest Anticipated Start Date: April
1, 2023.
VerDate Sep<11>2014
17:56 Jan 20, 2023
Jkt 259001
I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS) is
accepting applications for grants for the
4-in-1 Grant Program. This program is
authorized under the Snyder Act, 25
U.S.C. 13; the Transfer Act, 42 U.S.C.
2001(a); and Title V of the Indian Health
Care Improvement Act (IHCIA), at 25
U.S.C. 1653(c)–(e) (authorizing grants
for Health Promotion and Disease
Prevention (HP/DP) services,
Immunization services, and Mental
Health services), and 1660a (authorizing
grants for Alcohol and Substance Abuse
related services). This program is
described in the Assistance Listings
located at https://sam.gov/content/home
(formerly known as Catalog of Federal
Domestic Assistance) under 93.193.
Background
In the late 1960s, Urban Indian
community leaders began advocating at
the local, state, and Federal levels to
address the unmet health care needs of
Urban Indians, and requested health
care services and programs. These
efforts resulted in an increase of
preventative, medical, and behavioral
health services, but there was growing
recognition of challenges preventing
Urban Indians in seeking health care
services. To address these barriers,
advocacy focused on the development
of culturally appropriate activities that
were unique to the social, cultural, and
spiritual needs of American Indians and
Alaska Natives residing in urban
settings. Programs developed at that
time were staffed by volunteers in
storefront settings, with limited budgets,
offering primary care, outreach, and
referral services.
In response to efforts of the Urban
Indian community leaders, Congress
appropriated funds in 1966 through the
IHS for a pilot urban clinic in Rapid
City, South Dakota. In 1973, Congress
appropriated funds to study unmet
Urban Indian health needs in
Minneapolis, Minnesota. The findings
of this study documented cultural,
economic, and access barriers to health
care and led to congressional
appropriations to support emerging
Urban Indian clinics in several Bureau
of Indian Affairs relocation cities, e.g.,
Seattle, San Francisco, Tulsa, and
Dallas. In 1976, Congress passed the
IHCIA establishing the Urban Indian
health program, and reauthorized the
IHCIA in 2010 to improve the health
and well-being of all American Indians
and Alaska Natives, including Urban
Indians. The development of programs
for Urban Indians residing in urban
areas include HP/DP services,
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
immunization services, alcohol and
substance abuse related services, and
mental health services, hereafter
referred to as the ‘‘4-in-1 health
program.’’
Purpose
The purpose of this program is to
ensure the highest possible health status
for Urban Indians. Funding will be used
to support the 4-in-1 health program
objectives. These programs are integral
components of the IHS health care
delivery system. Funds from this effort
will ensure that comprehensive,
culturally acceptable personal and
public health services are available and
accessible to Urban Indians.
Required, Optional, and Allowable
Activities
Each awardee shall provide health
care services under this award only to
eligible Urban Indians living within the
urban center in which the Urban Indian
Organization (UIO) is situated. An
‘‘Urban Indian’’ eligible for services, as
codified at 25 U.S.C. 1603(13), (27), and
(28), includes any individual who:
1. Resides in an urban center, which
is any community that has a sufficient
Urban Indian population with unmet
health needs to warrant assistance
under the IHCIA, as determined by the
Secretary, Health and Human Services
(HHS), and who meets one or more of
the following criteria:
a. Irrespective of whether he or she
lives on or near a reservation, is a
member of a Tribe, band, or other
organized group of Indians, including:
i. those Tribes, bands, or groups
terminated since 1940, and
ii. those recognized now or in the
future by the state in which they reside,
or
b. Is a descendant, in the first or
second degree, of any such member
described in 1.a.; or
c. Is an Eskimo, or Aleut, or other
Alaska Native; or
d. Is a California Indian; 1 or
e. Is considered by the Secretary of
the Department of the Interior to be an
Indian for any purpose; or
f. Is determined to be an Indian under
regulations pertaining to Urban Indian
health that are promulgated by the
Secretary, HHS.
1 Consistent with 25 U.S.C. 1603(3), (13), (28),
and 1679, eligibility of California Indians may be
demonstrated by documentation that the
individual:
1. Is a descendant of an Indian who was residing
in the State of California on June 1, 1852;
2. Holds trust interests in public domain, national
forest, or Indian reservation allotments; or
3. Is listed on the plans for distribution of assets
of California Rancherias and reservations under the
Act of August 18, 1958 (72 Stat. 619), or is the
descendant of such an individual.
E:\FR\FM\23JAN1.SGM
23JAN1
]]>Agencies
[Federal Register Volume 88, Number 14 (Monday, January 23, 2023)]
[Notices]
[Pages 3999-4002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01145]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Notice of Privacy Act of 1974; System of Records
AGENCY: Office of Infectious Disease and HIV/AIDS Policy, Office of the
Assistant Secretary for Health, Office of the Secretary, Department of
Health and Human Services.
ACTION: Notice of a new system of records.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Privacy Act, the Department of Health
and Human Services (HHS) is establishing a new system of records to be
maintained by the Office of Infectious Disease and HIV/AIDS Policy
within the Office of the Assistant Secretary for Health (OASH/OIDP),
System No. 09-90-2101 ``HIV Prevention Medication Distribution
Records.'' The new system of records will consist of records about
individual patients who participate in the Ending the HIV Epidemic--
Pre-Exposure Prophylaxis Implementation and Distribution Services
Program (PrEP Program), which will provide donated HIV prevention
medication to patients in the United States who are at substantial risk
of acquiring the human immunodeficiency virus (HIV).
DATES: In accordance with 5 U.S.C. 552a(e)(4) and (11), this notice is
effective upon publication, subject to a 30-day period in which to
comment on the routine uses, described below. Please submit any
comments by February 22, 2023.
ADDRESSES: The public should submit comments on the new system of
records by email to [email protected].
FOR FURTHER INFORMATION CONTACT: General questions about the system of
records may be submitted to Ann Abercrombie, OASH/OIDP at (202) 401-
9588, or [email protected].
SUPPLEMENTARY INFORMATION: Within the U.S. Department of Health and
Human Services (HHS), the Office of the Assistant Secretary for Health
(OASH) leads development of agency-wide public health policy
recommendations and oversees core public health offices, including the
Office of the Surgeon General and the U.S. Public Health Service
Commissioned Corps, as well as 10 regional health offices across the
nation and 10 presidential and secretarial advisory committees. The
mission of the Office of Infectious Disease and HIV/AIDS Policy (OIDP)
is to provide strategic leadership and management, while encouraging
collaboration, coordination, and innovation among federal agencies and
stakeholders to reduce the burden of infectious diseases, including the
human immunodeficiency virus (HIV).
The initiative to End the HIV Epidemic in the U.S. is part of a
national HIV prevention and control effort to reduce the number of new
HIV infections by 75% in five years and 90% in 10 years. A key
component of the initiative is expanding access to HIV prevention
medication for patients who are at substantial risk of acquiring the
disease. Pursuant to a donation agreement executed May 8, 2019, a drug
manufacturer, Gilead Sciences, Inc. (Gilead), donated certain HIV
prevention medication (emtricitabine/tenofovir disoproxil fumarate and
emtricitabine/tenofovir alafenamide tablets, collectively referred to
as ``Product'') to HHS for distribution through the Ending the HIV
Epidemic--Pre-Exposure Prophylaxis (PrEP) Implementation and
Distribution Services Program (PrEP Program), which will be
administered by OASH/OIDP subject to the terms of the donation
agreement between Gilead and HHS. Under the terms of the donation
agreement, Gilead will donate Product for up to 200,000 individuals
each year up to end of 2030 or earlier. The PrEP Program, through a
contractor engaged by OASH/OIDP, will issue an enrollment card or
electronic enrollment confirmation, containing a unique identification
number, to each qualified eligible patient in the United States who
applies to the program (up to 200,000 individuals per year). This will
enable the patient to obtain the Product at no cost, either in person
or by mail, from a participating pharmacy. The contractor will operate
a mail order pharmacy to acquire the Product from Gilead and dispense
it to patients who elect to receive the Product by mail. The
[[Page 4000]]
contractor will also engage a subcontractor to serve as a claims
processor to verify the validity of enrollment identification numbers
for pharmacies before pharmacies dispense the Product, and to reimburse
the pharmacies' acquisition costs and taxes. All prescription and
shipping costs will be 100% covered by OIDP and the Gilead donation.
However, costs that patients incur for clinic visits and lab tests
required to remain eligible for the program are not covered by the
program.
The mail-order pharmacy and other pharmacies that wish to
participate in the program must sign an agreement with HHS agreeing
that they will donate their services (agreeing to be reimbursed only
for wholesale acquisition cost and taxes for the Product they
dispense). Participating pharmacies also sign an addendum with the
claims processor acknowledging that they will receive reimbursement for
wholesale acquisition cost and taxes only, with no dispensing or other
fees. The list of participating pharmacies is available on this website
https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/prep-pharmacies.
The claims processor (subcontractor) will have access to enrollment
identification numbers and the dates the numbers are valid (not other
information about patients). The contractor will collect and maintain
all records needed to determine patients' initial and continued
eligibility for the Program and to operate the mail-order pharmacy. The
contractor will, for example, obtain twice yearly confirmations of the
patient's continued eligibility from the patient and the patient's
prescribing health care provider; and, if the patient elects mail
order, the contractor will notify the provider to send the prescription
to the mail-order pharmacy to be filled. The mail-order pharmacy will
confirm the patient's shipping information and current eligibility for
the program, using the patient's enrollment identification number.
Dated: December 6, 2022.
Rucia A. Abercrombie,
Lead Management Analyst, OIDP.
SYSTEM NAME AND NUMBER:
HIV Prevention Medication Distribution Records, 09-90-2101.
SECURITY CLASSIFICATION:
Unclassified.
SYSTEM LOCATION:
The address of the agency component responsible for the system of
records is the Office of Infectious Disease and HIV/AIDS Policy (OASH/
OIDP), U.S. Department of Health & Human Services, 330 C St. SW--Suite
L100, Washington, DC 20024. The records will be housed in a contractor-
owned information technology (IT) system.
SYSTEM MANAGER(S):
Director, Office of Infectious Disease and HIV/AIDS Policy (OASH/
OIDP), Department of Health & Human Services, 330 C St. SW-Suite L100,
Washington, DC 20201, (202) 795-7697.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Authorization to collect and maintain the records is provided under
sections 301, 1702, and 1703 of the Public Health Service Act (42
U.S.C. 241, 300u-1, and 300u-2).
PURPOSE(S) OF THE SYSTEM:
The records in this system of records will be used to administer
the Pre-Exposure Prophylaxis (PrEP) Implementation and Distribution
Services Program (PrEP Program, or Program), the goal of which is to
distribute donated HIV prevention medication (Product) appropriately to
qualifying patients in the United States who are at high risk of
acquiring HIV, in order to reduce transmission of HIV. To administer
the Program, OASH/OIDP, through a contractor, will use the records for
these specific purposes:
To determine if patients who apply for enrollment in the
Program are eligible to receive the Product under the terms of the
donation agreement between HHS and the drug manufacturer, Gilead
Sciences, Inc. (Gilead);
To enroll qualified eligible patients in the Program and
issue an enrollment card or confirmation containing a unique enrollment
identification number to each enrolled patient, and, thereafter, to
confirm each patient's continued eligibility to remain enrolled in the
Program;
To verify the validity of enrollment identification
numbers, for Product dispensing and cost reimbursement purposes.
To reimburse participating pharmacies' wholesale
acquisition cost and taxes, for the Product they dispense to patients;
To monitor and audit the Program to prevent, detect, and
address any program violations, errors, fraud, and improper
distribution of benefits, to ensure the integrity of the Program; and
To compile statistics for reports and to conduct research
to evaluate the effectiveness of the Program.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
The records will be about patients who apply for Product through
the PrEP Program.
CATEGORIES OF RECORDS IN THE SYSTEM:
The records will consist of application records, enrolled patient
records, and reimbursement records.
Application records will include information needed to
identify a patient and verify the patient's initial eligibility to be
enrolled in the Program, to include: patient name, date of birth,
location, and the last four digits of the patient's Social Security
Number; name and address of prescribing practitioner and practice
location; the patient's certification that the patient is not covered
by a health insurance plan or policy that covers outpatient
prescription drugs; and the patient's consent to information sharing
between OASH/OIDP, its contractor, the Product manufacturer, and the
patient's prescribing health care provider. A patient (or the patient's
health care provider) can submit an application to the program through
the Program's online portal or call center hub. Demographic information
(race, ethnicity, gender identity, and sex assigned at birth) will be
included in both application records and enrolled patient records, for
statistical purposes only, to use in government analyses of the data at
an aggregate level.
Enrolled patient records will include the above
application information; a unique identifier assigned to the patient by
the OASH/OIDP contractor (included on the patient's enrollment card or
enrollment confirmation); twice yearly confirmations of the patient's
continued eligibility (e.g., negative HIV status based on quarterly HIV
tests) from the patient's prescribing health care provider; amount of
Product dispensed to the patient, reported by the participating
pharmacy; and periodic re-certification(s) from the patient attesting
that the patient is not covered by a health insurance plan or policy
that covers outpatient prescription drugs. The records will also
indicate whether the patient elected to receive Product by mail or was
issued an enrollment card to use to obtain the Product from the
participating pharmacy's customary retail inventory.
The claims processor will use the enrollment
identification number provided by a participating pharmacy to verify
patient eligibility in the program and to generate a claim number used
to reimburse the pharmacy's wholesale
[[Page 4001]]
acquisition cost and taxes for the Product dispensed.
RECORD SOURCE CATEGORIES:
Information in the patient's application records and enrolled
patient records will be obtained directly from the patient or the
patient's prescribing health care provider. The OASH/OIDP contractor
will assign the unique enrollment identification number to the patient
upon enrollment.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND PURPOSES OF SUCH USES:
In addition to other disclosures that may be made without the
patient's prior, written consent which are authorized directly in the
Privacy Act at 5 U.S.C. 552a(b)(1)-(b)(2) and (b)(4)-(11), HHS may
disclose information about a patient from this system of records to
parties outside the agency pursuant to these routine uses.
1. Records may be disclosed to agency contractors, consultants, or
others who have been engaged by the agency to assist in accomplishment
of an HHS function relating to the purposes of this system of records
and who need to have access to the records in order to assist HHS. Note
that this routine use will authorize any such disclosures which are not
adequately covered by the patient's consent provided on or with the
enrollment application. Any contractor will be required to comply with
the requirements of the Privacy Act.
2. Records may be disclosed to a patient's prescribing healthcare
provider to verify the patient's initial, or continued, eligibility for
enrollment. Note that this routine use will authorize any such
disclosures which are not adequately covered by the patient's consent
on or with the enrollment application.
3. Records may be disclosed to Gilead Sciences, Inc., to ensure
individuals are not actively enrolling in both Gilead's Advancing
Access program and HHS' Ready, Set, PrEP program simultaneously. Note
that this routine use will authorize any such disclosures which are not
adequately covered by the patient's consent on or with the enrollment
application.
4. Information may be disclosed to the U.S. Department of Justice
(DOJ) or to a court or other tribunal in litigation or other
proceedings, when the agency or any component thereof, or any employee
of the agency in his or her official capacity, or any employee of the
agency in his or her individual capacity where DOJ has agreed to
represent the employee, or the United State Government is a party to
the proceedings or has an interest in such proceedings and, by careful
review, HHS determines that the records are both relevant and necessary
to the proceedings.
5. Records may be disclosed to a congressional office from the
record of an individual in response to a written inquiry from the
congressional office made at the written request of that individual.
6. Records may be disclosed to representatives of the National
Archives and Records Administration (NARA) during records management
inspections conducted pursuant to 44 U.S.C. 2904 and 2906.
7. Records may be disclosed to appropriate agencies, entities, and
persons when (1) HHS suspects or has confirmed that there has been a
breach of the system of records, (2) HHS has determined that as a
result of the suspected or confirmed breach there is a risk of harm to
individuals, HHS (including its information systems, programs, and
operations), the federal government, or national security, and (3) the
disclosure made to such agencies, entities, and persons is reasonably
necessary to assist in connection with HHS's efforts to respond to the
suspected or confirmed breach or to prevent, minimize, or remedy such
harm.
8. Records may be disclosed to another federal agency or federal
entity, when HHS determines that information from this system of
records is reasonably necessary to assist the recipient agency or
entity in (1) responding to a suspected or confirmed breach or (2)
preventing, minimizing, or remedying the risk of harm to individuals,
the recipient agency or entity (including its information systems,
programs, and operations), the federal government, or national
security, resulting from a suspected or confirmed breach.
POLICIES AND PRACTICES FOR STORAGE OF RECORDS:
The records will be stored on electronic media.
POLICIES AND PRACTICES FOR RETRIEVAL OF RECORDS:
Records will be retrieved by the patient's unique enrollment
identification number.
POLICIES AND PRACTICES FOR RETENTION AND DISPOSAL OF RECORDS:
OASH is developing a disposition schedule for the records and plans
to propose a retention period of approximately 10 years for the
records. Until the schedule has been submitted to and approved by the
National Archives and Records Administration (NARA), the records will
be retained indefinitely.
ADMINISTRATIVE, TECHNICAL, AND PHYSICAL SAFEGUARDS:
The records will be safeguarded in accordance with applicable laws,
rules and policies, including the pertinent National Institutes of
Standards and Technology (NIST) publications and OMB Circular A-130,
Managing Information as a Strategic Resource. Records will be protected
from unauthorized access through appropriate administrative, physical,
and technical safeguards. Safeguards will conform to the HHS
Information Security and Privacy Program, https://www.hhs.gov/ocio/securityprivacy/.
The safeguards will include protecting the facilities where records
are stored or accessed with security guards, badges and cameras;
limiting access to electronic databases to authorized users based on
roles and the principle of least privilege and either two-factor
authentication or user name and password; using a secured operating
system protected by encryption, firewalls, and intrusion detection
systems; using an SSL connection for secure encrypted transmissions;
requiring encryption for records stored on removable media; and
training personnel in Privacy Act and information security
requirements. Records that are eligible for destruction will be
disposed of using secure destruction methods prescribed by NIST SP 800-
88.
RECORD ACCESS PROCEDURES:
An individual seeking access to records about him or her in this
system of records must submit a written access request to the System
Manager (see above ``System Manager'' section). The request must
contain the requester's full name, address, and signature. The request
should also contain the requester's contact information and sufficient
identifying particulars (such as, the unique identifier from the
individual's enrollment card or enrollment confirmation) to enable HHS
to locate the requested records. To verify the requester's identity,
the signature must be notarized or the request must include the
requester's written certification that the requester is the individual
who the requester claims to be and that the requester understands that
the knowing and willful request for or acquisition of records
pertaining to an individual under false pretenses is a criminal offense
subject to a fine of up to $5,000. Requesters may also ask for
[[Page 4002]]
an accounting of disclosures that have been made of records about them,
if any.
CONTESTING RECORD PROCEDURES:
An individual seeking to amend a record about him or her in this
system of records must submit a written amendment request to the System
Manager (see above ``System Manager'' section), containing the same
information required for an access request and including verification
of the requester's identity in the same manner required for an access
request. In addition, the request must reasonably identify the record
and specify the information being contested, the corrective action
sought, and the reasons for requesting the correction; and should
include supporting information, showing how the record is inaccurate,
incomplete, untimely, or irrelevant.
NOTIFICATION PROCEDURES:
An individual who wishes to know if this system of records contains
records about that individual must submit a written notification
request to the System Manager (see above ``System Manager'' section).
The request must contain the same information required for an access
request and and must include verification of the requester's identity
in the same manner required for an access request.
EXEMPTIONS PROMULGATED FOR THE SYSTEM:
None.
HISTORY:
None.
[FR Doc. 2023-01145 Filed 1-20-23; 8:45 am]
BILLING CODE 4150-43-P
