Rescission of Humanitarian Exemption for All Afghan Evacuees Subject to CDC's Global Testing Order, 53659-53660 [2021-20987]
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Federal Register / Vol. 86, No. 185 / Tuesday, September 28, 2021 / Notices
Background
The Patient Safety Act, 42 U.S.C.
299b–21 to 299b–26, and the related
Patient Safety Rule, 42 CFR part 3,
published in the Federal Register on
November 21, 2008 (73 FR 70732–
70814), establish a framework by which
individuals and entities that meet the
definition of provider in the Patient
Safety Rule may voluntarily report
information to PSOs listed by AHRQ, on
a privileged and confidential basis, for
the aggregation and analysis of patient
safety work product.
The Patient Safety Act authorizes the
listing of PSOs, which are entities or
component organizations whose
mission and primary activity are to
conduct activities to improve patient
safety and the quality of health care
delivery.
HHS issued the Patient Safety Rule to
implement the Patient Safety Act.
AHRQ administers the provisions of the
Patient Safety Act and Patient Safety
Rule relating to the listing and operation
of PSOs. The Patient Safety Rule
authorizes AHRQ to list as a PSO an
entity that attests that it meets the
statutory and regulatory requirements
for listing. A PSO can be ‘‘delisted’’ if
it is found to no longer meet the
requirements of the Patient Safety Act
and Patient Safety Rule, when a PSO
chooses to voluntarily relinquish its
status as a PSO for any reason, or when
a PSO’s listing expires. Section 3.108(d)
of the Patient Safety Rule requires
AHRQ to provide public notice when it
removes an organization from the list of
PSOs.
AHRQ has accepted a notification of
proposed voluntary relinquishment
from the Chicago Breast Cancer Quality
Consortium to voluntarily relinquish its
status as a PSO. Accordingly, the
Chicago Breast Cancer Quality
Consortium, P0074, was delisted
effective at 12:00 Midnight ET (2400) on
September 14, 2021.
Chicago Breast Cancer Quality
Consortium has patient safety work
product (PSWP) in its possession. The
PSO will meet the requirements of
section 3.108(c)(2)(i) of the Patient
Safety Rule regarding notification to
providers that have reported to the PSO
and of section 3.108(c)(2)(ii) regarding
disposition of PSWP consistent with
section 3.108(b)(3). According to section
3.108(b)(3) of the Patient Safety Rule,
the PSO has 90 days from the effective
date of delisting and revocation to
complete the disposition of PSWP that
is currently in the PSO’s possession.
More information on PSOs can be
obtained through AHRQ’s PSO website
at https://www.pso.ahrq.gov.
VerDate Sep<11>2014
16:35 Sep 27, 2021
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Dated: September 23, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021–21072 Filed 9–27–21; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Rescission of Humanitarian Exemption
for All Afghan Evacuees Subject to
CDC’s Global Testing Order
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), located
within the Department of Health and
Human Services (HHS), announces
rescission of the temporary
humanitarian exemption to the agency’s
Requirement for Negative Pre-Departure
COVID–19 Test Result, which was
previously granted for individuals
relocating to the United States from
Afghanistan (‘‘Afghan Evacuees’’),
including U.S. citizens, lawful
permanent residents (LPRs), third
country nationals, and Afghans at risk,
including Afghan Special Immigrant
Visa (SIV) applicants.
DATES: This temporary humanitarian
exemption to the Global Testing Order
was rescinded September 20, 2021.
FOR FURTHER INFORMATION CONTACT:
Tiffany Brown, Deputy Chief of Staff,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS
H21–10, Atlanta, GA 30329. Phone:
404–639–7000. Email: cdcregulations@
cdc.gov.
SUPPLEMENTARY INFORMATION: On
January 12, 2021, CDC issued an Order
requiring all air passengers arriving to
the U.S. from a foreign country to get
tested no more than 3 days before their
flight departs and to present the
negative result or documentation of
having recovered from COVID–19 to the
airline or aircraft operator before
boarding the flight. A copy of the Order
was published in the Federal Register
on January 21, 2021 (86 FR 6337) and
went into effect January 26, 2021.
In August 2021, the U.S. Department
of State (DOS) issued a series of Security
Alerts for Afghanistan due to increased
Taliban activity throughout the country,
including the capital of Kabul. In
response to a request from DOS on
August 15, 2021, CDC and the U.S.
Department of Health and Human
SUMMARY:
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
53659
Services (HHS) granted a blanket
humanitarian exemption to CDC’s Order
to expedite the evacuation of U.S.
citizens, lawful permanent residents
(LPRs), third country nationals, and
Afghans at risk, including Afghan
Special Immigrant Visa (SIV) applicants,
while adhering to other COVID–19
mitigation guidance issued by CDC.
The exemption, which is being
administered with the assistance of DOS
and other cooperating Federal and state
agencies, was granted with the
following conditions: (1) The CDC Order
requiring mask use for passengers and
crew on air conveyances bound for the
United States should be followed to the
extent possible; (2) all efforts should be
made to test for COVID–19 at a transit
location prior to arrival in the United
States, and to provide test
documentation to the traveler, which
can be presented upon arrival, and if
this cannot be done, individuals
(travelers) arriving are required to
undergo COVID–19 testing immediately
upon arrival to the first port of entry in
the United States; (3) individuals who
test positive are required to isolate prior
to continuing on commercial
transportation to their final destination;
and (4) family members of those testing
positive may be required to adhere to
self-quarantine recommendations as
stipulated by CDC or state and local
health authorities at the arrival location.
Beginning September 20, 2021, all
Afghan Evacuees arriving in the United
States will have to meet negative predeparture COVID–19 test requirements
or documentation of recovery. This
means evacuees will need to be tested
no more than three days before
departure to the United States and be
able to present the negative result or
provide documentation of having
recovered from COVID–19 within the
last 90 days, to the airline or aircraft
operator and upon request of United
States Government authorities on arrival
in the United States.
This requirement applies to all
Afghan Evacuees arriving in the United
States on any flight including U.S.
Government-owned or -contracted,
commercial, private, and general and
business aviation (chartered) flights
coming to the United States.
CDC is rescinding the humanitarian
exemption because:
• The Department of State (DOS) has
completed the emergency evacuation
and concluded the transport of evacuees
out of Afghanistan;
• With DOS’s conclusion of
emergency evacuation from
Afghanistan, there is a need to resume
appropriate health interventions,
including pre-departure COVID–19
E:\FR\FM\28SEN1.SGM
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53660
Federal Register / Vol. 86, No. 185 / Tuesday, September 28, 2021 / Notices
testing, before travel into the United
States;
• Designated U.S. arrival Ports of
Entry with specific testing operations
and other services for Afghan Evacuees,
which were specifically set up for early
urgent evacuation arrival support, have
been discontinued in the United States;
and
• Evacuees who are still outside of
the United States are in safe locations
where testing can be accessed before
traveling.
Authority: The CDC Director has
issued this Notice authorizing the
rescission of this temporary
humanitarian exemption for individuals
relocating to the United States from
Afghanistan and reimposing the
agency’s Requirement for Negative PreDeparture COVID–19 Test Result
pursuant to Sections 361 of the Public
Health Service Act, 42 U.S.C. 264, and
implementing regulations at 42 CFR
71.20 and 71.31(b).
This Notice is issued to inform the
public of this action.
Sherri Berger,
Chief of Staff, Centers for Disease Control
and Prevention.
[FR Doc. 2021–20987 Filed 9–27–21; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3413–FN]
Medicare Program: Application by the
Association of Diabetes Care and
Education Specialists (ADCES) for
Continued CMS Approval of Its
Diabetes Outpatient Self-Management
Training Program
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final notice.
AGENCY:
This final notice announces
our decision to approve the Association
of Diabetes Care and Education
Specialists (ADCES) application for
continued recognition as a national
accrediting organization (AO) for
accrediting entities that wish to furnish
diabetes outpatient self-management
training services to Medicare
beneficiaries.
SUMMARY:
This final notice is effective on
September 27, 2021 through September
27, 2027.
FOR FURTHER INFORMATION CONTACT:
Shannon Freeland, (410) 786–4348.
Caroline Gallaher, (410) 786–8705.
DATES:
VerDate Sep<11>2014
16:35 Sep 27, 2021
Jkt 253001
Lillian Williams, (410) 786–8636.
SUPPLEMENTARY INFORMATION:
I. Background
Diabetes outpatient self-management
training services are defined in section
1861(qq)(1) of the Social Security Act
(the Act) as ‘‘educational and training
services furnished (at such times as the
Secretary determines appropriate) to an
individual with diabetes by a certified
provider (as described in paragraph
(2)(A)) in an outpatient setting by an
individual or entity who meets the
quality standards described in
paragraph (2)(B), but only if the
physician who is managing the
individual’s diabetic condition certifies
that such services are needed under a
comprehensive plan of care related to
the individual’s diabetic condition to
ensure therapy compliance or to provide
the individual with necessary skills and
knowledge (including skills related to
the self-administration of injectable
drugs) to participate in the management
of the individual’s condition.’’
In addition, section 1861(qq)(2)(A) of
the Act describes a ‘‘certified provider’’
as a physician, or other individual or
entity designated by the Secretary of the
Department of Health and Human
Services (the Secretary), that, in
addition to providing diabetes
outpatient self-management training
services, provides other items or
services for which payment may be
made under this title. Section
1861(qq)(2)(B) of the Act further
specifies that a physician, or such other
individual or entity, must meet the
quality standards established by the
Secretary, except that the physician or
other individual or entity shall be
deemed to have met such standards if
the physician or other individual or
entity meets applicable standards
originally established by the National
Diabetes Advisory Board and
subsequently revised by organizations
who participated in the establishment of
standards by such Board or is
recognized by an organization that
represents individuals (including
individuals under this title) with
diabetes as meeting standards for
furnishing the services.
Section 1865 of the Act also permits
the Secretary to use accrediting bodies
to determine whether a provider entity
meets Medicare regulatory quality
standards, such as those established for
diabetes outpatient self-management
training programs. These accrediting
bodies determine whether a diabetes
outpatient self-management training
supplier meets the Medicare regulatory
quality standards established for
diabetes outpatient self-management
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
training service programs. A national
accrediting organization (AO) must be
approved by the Centers for Medicare &
Medicaid Services (CMS) and meet the
standards and requirements specified in
42 CFR part 410, subpart H, to qualify
for Medicare deeming authority.
Our regulations regarding the
application procedures for diabetes
outpatient self-management training
AOs seeking CMS approval are set forth
at 42 CFR 410.142. A national
accreditation organization applying for
deeming authority must provide CMS
with reasonable assurance that it will
require the diabetes outpatient selfmanagement training suppliers it
accredits to meet the CMS’ quality
standards, the National Standards for
Diabetes Self-Management Education
and Support (NSDSMES) standards, or
an alternative set of standards that meet
or exceed our requirements that have
been developed by that AO and that
have been approved by CMS (see 42
CFR 410.144).
Section 410.142(a) of our regulations
states that ‘‘CMS may approve and
recognize a nonprofit organization with
demonstrated experience in
representing the interests of individuals
with diabetes to accredit entities to
furnish training.’’ Therefore, all diabetes
outpatient self-management training
AOs must be not-for-profit
organizations.
Section 410.142(b) of our regulations
require a diabetes outpatient selfmanagement training AO to submit
specific documents and information
with their application, as discussed in
section II of this final notice.
II. Provisions of the Proposed Notice
On April 27, 2021, we published a
proposed notice in the Federal Register
(86 FR 22208) acknowledging receipt of
the Association of Diabetes Care and
Education Specialists (ADCES) request
for continued CMS approval of its
diabetes outpatient self-management
training accreditation program. In that
proposed notice, we detailed our
evaluation criteria.
Under section 1861(qq) of the Act and
our regulations at § 410.142, we
conducted a review of the ADCES’s
diabetes outpatient self-management
training program application using the
criteria specified by our regulations,
which include authorization for CMS to
conduct an onsite visit to verify
information contained in the
organization’s application. For an onsite
visit, the CMS review team travels to the
AO’s corporate office to review specific
information and documents. An onsite
visit is typically part of every
application review. However, due to the
E:\FR\FM\28SEN1.SGM
28SEN1
Agencies
[Federal Register Volume 86, Number 185 (Tuesday, September 28, 2021)]
[Notices]
[Pages 53659-53660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20987]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Rescission of Humanitarian Exemption for All Afghan Evacuees
Subject to CDC's Global Testing Order
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), located
within the Department of Health and Human Services (HHS), announces
rescission of the temporary humanitarian exemption to the agency's
Requirement for Negative Pre-Departure COVID-19 Test Result, which was
previously granted for individuals relocating to the United States from
Afghanistan (``Afghan Evacuees''), including U.S. citizens, lawful
permanent residents (LPRs), third country nationals, and Afghans at
risk, including Afghan Special Immigrant Visa (SIV) applicants.
DATES: This temporary humanitarian exemption to the Global Testing
Order was rescinded September 20, 2021.
FOR FURTHER INFORMATION CONTACT: Tiffany Brown, Deputy Chief of Staff,
Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS
H21-10, Atlanta, GA 30329. Phone: 404-639-7000. Email:
[email protected].
SUPPLEMENTARY INFORMATION: On January 12, 2021, CDC issued an Order
requiring all air passengers arriving to the U.S. from a foreign
country to get tested no more than 3 days before their flight departs
and to present the negative result or documentation of having recovered
from COVID-19 to the airline or aircraft operator before boarding the
flight. A copy of the Order was published in the Federal Register on
January 21, 2021 (86 FR 6337) and went into effect January 26, 2021.
In August 2021, the U.S. Department of State (DOS) issued a series
of Security Alerts for Afghanistan due to increased Taliban activity
throughout the country, including the capital of Kabul. In response to
a request from DOS on August 15, 2021, CDC and the U.S. Department of
Health and Human Services (HHS) granted a blanket humanitarian
exemption to CDC's Order to expedite the evacuation of U.S. citizens,
lawful permanent residents (LPRs), third country nationals, and Afghans
at risk, including Afghan Special Immigrant Visa (SIV) applicants,
while adhering to other COVID-19 mitigation guidance issued by CDC.
The exemption, which is being administered with the assistance of
DOS and other cooperating Federal and state agencies, was granted with
the following conditions: (1) The CDC Order requiring mask use for
passengers and crew on air conveyances bound for the United States
should be followed to the extent possible; (2) all efforts should be
made to test for COVID-19 at a transit location prior to arrival in the
United States, and to provide test documentation to the traveler, which
can be presented upon arrival, and if this cannot be done, individuals
(travelers) arriving are required to undergo COVID-19 testing
immediately upon arrival to the first port of entry in the United
States; (3) individuals who test positive are required to isolate prior
to continuing on commercial transportation to their final destination;
and (4) family members of those testing positive may be required to
adhere to self-quarantine recommendations as stipulated by CDC or state
and local health authorities at the arrival location.
Beginning September 20, 2021, all Afghan Evacuees arriving in the
United States will have to meet negative pre-departure COVID-19 test
requirements or documentation of recovery. This means evacuees will
need to be tested no more than three days before departure to the
United States and be able to present the negative result or provide
documentation of having recovered from COVID-19 within the last 90
days, to the airline or aircraft operator and upon request of United
States Government authorities on arrival in the United States.
This requirement applies to all Afghan Evacuees arriving in the
United States on any flight including U.S. Government-owned or -
contracted, commercial, private, and general and business aviation
(chartered) flights coming to the United States.
CDC is rescinding the humanitarian exemption because:
The Department of State (DOS) has completed the emergency
evacuation and concluded the transport of evacuees out of Afghanistan;
With DOS's conclusion of emergency evacuation from
Afghanistan, there is a need to resume appropriate health
interventions, including pre-departure COVID-19
[[Page 53660]]
testing, before travel into the United States;
Designated U.S. arrival Ports of Entry with specific
testing operations and other services for Afghan Evacuees, which were
specifically set up for early urgent evacuation arrival support, have
been discontinued in the United States; and
Evacuees who are still outside of the United States are in
safe locations where testing can be accessed before traveling.
Authority: The CDC Director has issued this Notice authorizing the
rescission of this temporary humanitarian exemption for individuals
relocating to the United States from Afghanistan and reimposing the
agency's Requirement for Negative Pre-Departure COVID-19 Test Result
pursuant to Sections 361 of the Public Health Service Act, 42 U.S.C.
264, and implementing regulations at 42 CFR 71.20 and 71.31(b).
This Notice is issued to inform the public of this action.
Sherri Berger,
Chief of Staff, Centers for Disease Control and Prevention.
[FR Doc. 2021-20987 Filed 9-27-21; 8:45 am]
BILLING CODE 4163-18-P