Medicare and Medicaid Programs: Application From the American Association for Accreditation of Ambulatory Surgery Facilities dba QUAD A for Continued CMS-Approval of Its Outpatient Physical Therapy (OPT) Accreditation Program, 83689-83691 [2024-23930]
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Federal Register / Vol. 89, No. 201 / Thursday, October 17, 2024 / Notices
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[FR Doc. 2024–23885 Filed 10–16–24; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Meeting of the Board of Scientific
Counselors, Office of Readiness and
Response
Centers for Disease Control and
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ACTION: Notice of meeting.
AGENCY:
In accordance with the
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SUMMARY:
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18:31 Oct 16, 2024
Jkt 265001
lines). Time will be available for public
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Business Initiatives, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
PO 00000
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83689
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Office of Strategic Business
Initiatives, Office of the Chief Operating
Officer, Centers for Disease Control and
Prevention.
[FR Doc. 2024–23926 Filed 10–16–24; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3466–PN]
Medicare and Medicaid Programs:
Application From the American
Association for Accreditation of
Ambulatory Surgery Facilities dba
QUAD A for Continued CMS-Approval
of Its Outpatient Physical Therapy
(OPT) Accreditation Program
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice with request for
comment.
AGENCY:
This notice acknowledges the
receipt of an application from the
American Association for Accreditation
of Ambulatory Surgery Facilities, dba
QUAD A, for continued recognition as
a national accrediting organization for
outpatient physical therapy providers
that wish to participate in the Medicare
or Medicaid programs.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on November 18, 2024.
ADDRESSES: In commenting, refer to file
code CMS–3466–PN. Because of staff
and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
Comments, including mass comment
submissions, must be submitted in one
of the following three ways (please
choose only one of the ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the ‘‘Submit a comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–3466–PN, P.O. Box 8010,
Baltimore, MD 21244–8010.
SUMMARY:
E:\FR\FM\17OCN1.SGM
17OCN1
83690
Federal Register / Vol. 89, No. 201 / Thursday, October 17, 2024 / Notices
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address ONLY: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–3466–PN,
Mail Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Caecilia Andrews, (410) 786–2190. Joy
Webb, (410) 786–1667.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following
website as soon as possible after they
have been received: https://
www.regulations.gov. Follow the search
instructions on that website to view
public comments. CMS will not post on
Regulations.gov public comments that
make threats to individuals or
institutions or suggest that the
commenter will take actions to harm an
individual. CMS continues to encourage
individuals not to submit duplicative
comments. We will post acceptable
comments from multiple unique
commenters even if the content is
identical or nearly identical to other
comments.
ddrumheller on DSK120RN23PROD with NOTICES1
I. Background
A healthcare provider may enter into
an agreement with Medicare to
participate in the program as a provider
of outpatient physical therapy (OPT)
provided certain requirements are met.
Section 1861(p)(4) of the Social Security
Act (the Act), establishes distinct
criteria for facilities seeking designation
as an OPT. Regulations concerning
Medicare provider agreements in
general are at 42 CFR part 489 and those
pertaining to the survey and
certification for Medicare participation
of providers and certain types of
suppliers are at part 488. The
regulations at part 485, subpart H
specify the conditions that a provider
must meet to participate in the Medicare
program as an OPT.
Generally, to enter into an agreement,
an OPT must first be certified by a state
survey agency (SA) as complying with
the conditions or requirements set forth
VerDate Sep<11>2014
18:31 Oct 16, 2024
Jkt 265001
in part 485 of our Medicare regulations.
Thereafter, the OPT is subject to regular
surveys by an SA to determine whether
it continues to meet these requirements.
Section 1865(a)(1) of the Act provides
that, if a provider entity demonstrates
through accreditation by a Centers for
Medicare & Medicaid Services (CMS)
approved national accrediting
organization (AO) that all applicable
Medicare conditions are met or
exceeded, we may deem that provider
entity as having met the requirements.
Accreditation by an AO is voluntary and
is not required for Medicare
participation.
If an AO is recognized by the
Secretary of the Department of Health
and Human Services as having
standards for accreditation that meet or
exceed Medicare requirements, any
provider entity accredited by the
national accrediting body’s approved
program may be deemed to meet the
Medicare conditions. The AO applying
for approval of its accreditation program
under part 488, subpart A, must provide
CMS with reasonable assurance that the
AO requires the accredited provider
entities to meet requirements that are at
least as stringent as the Medicare
conditions. Our regulations concerning
the approval of AOs are set forth at
§ 488.5.
The QUAD A’s current term of
approval for its OPT program expires
April 4, 2025.
II. Approval of Deeming Organization
Section 1865(a)(2) of the Act and our
regulations at § 488.5 require that our
findings concerning review and
approval of an AO’s requirements
consider, among other factors, the
applying AO’s requirements for
accreditation; survey procedures;
resources for conducting required
surveys; capacity to furnish information
for use in enforcement activities;
monitoring procedures for provider
entities found not in compliance with
the conditions or requirements; and
ability to provide CMS with the
necessary data for validation.
Section 1865(a)(3)(A) of the Act
further requires that we publish, within
60 days of receipt of an organization’s
complete application, a notice that
identifies the national accrediting body
making the request, describes the nature
of the request, and provides at least a
30-day public comment period. We have
210 days from the receipt of a complete
application to publish notice of
approval or denial of the application.
The purpose of this proposed notice
is to inform the public of QUAD A’s
request for continued CMS-approval of
its OPT accreditation program. This
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notice also solicits public comment on
whether QUAD A’s requirements meet
or exceed the Medicare conditions for
participation (CoPs) for OPTs.
III. Evaluation of Deeming Authority
Request
QUAD A submitted all the necessary
materials to enable us to make a
determination concerning its request for
continued CMS-approval of its OPT
accreditation program. This application
was determined to be complete on
September 9, 2024. Under section
1865(a)(2) of the Act and § 488.5, our
review and evaluation of QUAD A will
be conducted in accordance with, but
not necessarily limited to, the following
factors:
• The equivalency of QUAD A’s
standards for OPTs as compared with
Medicare’s CoPs for OPTs.
• QUAD A’s survey process to
determine the following:
++ The composition of the survey
team, surveyor qualifications, and the
ability of the organization to provide
continuing surveyor training.
++ The comparability of QUAD A’s
processes to those of State agencies,
including survey frequency, and the
ability to investigate and respond
appropriately to complaints against
accredited facilities.
++ QUAD A’s processes and
procedures for monitoring an OPT
found out of compliance with QUAD
A’s program requirements. These
monitoring procedures are used only
when QUAD A identifies
noncompliance. If noncompliance is
identified through validation reviews or
complaint surveys, the State survey
agency monitors corrections as specified
at § 488.9(c)(1).
++ QUAD A’s capacity to report
deficiencies to the surveyed facilities
and respond to the facility’s plan of
correction in a timely manner.
++ QUAD A’s capacity to provide
CMS with electronic data and reports
necessary for the effective validation
and assessment of the organization’s
survey process.
++ The adequacy of QUAD A’s staff
and other resources, and its financial
viability.
++ QUAD A’s capacity to adequately
fund required surveys.
++ QUAD A’s policies with respect to
whether surveys are announced or
unannounced, to ensure that surveys are
unannounced.
++ QUAD A’s policies and
procedures to avoid conflicts of interest,
including the appearance of conflicts of
interest, involving individuals who
conduct surveys or participate in
accreditation decisions.
E:\FR\FM\17OCN1.SGM
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Federal Register / Vol. 89, No. 201 / Thursday, October 17, 2024 / Notices
++ QUAD A’s agreement to provide
CMS with a copy of the most current
accreditation survey together with any
other information related to the survey
as CMS may require (including
corrective action plans).
IV. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
V. Response to Public Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
The Administrator of the Centers for
Medicare & Medicaid Services (CMS),
Chiquita Brooks-LaSure, having
reviewed and approved this document,
authorizes Vanessa Garcia, who is the
Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
Vanessa Garcia,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2024–23930 Filed 10–16–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–D–4774]
Temporary Policies for Compounding
Certain Parenteral Drug Products;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ddrumheller on DSK120RN23PROD with NOTICES1
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a final
guidance for industry entitled
‘‘Temporary Policies for Compounding
Certain Parenteral Drug Products.’’ As of
October 10, 2024, pursuant to the Public
Health Service Act (PHS Act),
SUMMARY:
VerDate Sep<11>2014
18:31 Oct 16, 2024
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Department of Health and Human
Services (HHS) Secretary Becerra has
determined that public health
emergencies (PHEs) exist as a result of
the consequences of Hurricane Helene
in the States of North Carolina, Florida,
Georgia, Tennessee, and South Carolina,
and as a result of the consequences of
Hurricane Milton in the State of Florida.
In late September 2024, Hurricane
Helene had a devastating impact on one
of the largest manufacturers of certain
intravenous and peritoneal dialysis
solutions in the United States. This
guidance describes the FDA’s regulatory
and enforcement priorities regarding the
compounding of certain parenteral drug
products by outsourcing facilities and
by State-licensed pharmacies and
Federal facilities that are not registered
with FDA as outsourcing facilities.
DATES: The announcement of the
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Submit written/paper submissions as
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83691
• For written/paper comments
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Instructions: All submissions received
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E:\FR\FM\17OCN1.SGM
17OCN1
Agencies
[Federal Register Volume 89, Number 201 (Thursday, October 17, 2024)]
[Notices]
[Pages 83689-83691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23930]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3466-PN]
Medicare and Medicaid Programs: Application From the American
Association for Accreditation of Ambulatory Surgery Facilities dba QUAD
A for Continued CMS-Approval of Its Outpatient Physical Therapy (OPT)
Accreditation Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice with request for comment.
-----------------------------------------------------------------------
SUMMARY: This notice acknowledges the receipt of an application from
the American Association for Accreditation of Ambulatory Surgery
Facilities, dba QUAD A, for continued recognition as a national
accrediting organization for outpatient physical therapy providers that
wish to participate in the Medicare or Medicaid programs.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on November 18,
2024.
ADDRESSES: In commenting, refer to file code CMS-3466-PN. Because of
staff and resource limitations, we cannot accept comments by facsimile
(FAX) transmission.
Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to https://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-3466-PN, P.O. Box 8010,
Baltimore, MD 21244-8010.
[[Page 83690]]
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-3466-PN, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Caecilia Andrews, (410) 786-2190. Joy
Webb, (410) 786-1667.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following
website as soon as possible after they have been received: https://www.regulations.gov. Follow the search instructions on that website to
view public comments. CMS will not post on Regulations.gov public
comments that make threats to individuals or institutions or suggest
that the commenter will take actions to harm an individual. CMS
continues to encourage individuals not to submit duplicative comments.
We will post acceptable comments from multiple unique commenters even
if the content is identical or nearly identical to other comments.
I. Background
A healthcare provider may enter into an agreement with Medicare to
participate in the program as a provider of outpatient physical therapy
(OPT) provided certain requirements are met. Section 1861(p)(4) of the
Social Security Act (the Act), establishes distinct criteria for
facilities seeking designation as an OPT. Regulations concerning
Medicare provider agreements in general are at 42 CFR part 489 and
those pertaining to the survey and certification for Medicare
participation of providers and certain types of suppliers are at part
488. The regulations at part 485, subpart H specify the conditions that
a provider must meet to participate in the Medicare program as an OPT.
Generally, to enter into an agreement, an OPT must first be
certified by a state survey agency (SA) as complying with the
conditions or requirements set forth in part 485 of our Medicare
regulations. Thereafter, the OPT is subject to regular surveys by an SA
to determine whether it continues to meet these requirements. Section
1865(a)(1) of the Act provides that, if a provider entity demonstrates
through accreditation by a Centers for Medicare & Medicaid Services
(CMS) approved national accrediting organization (AO) that all
applicable Medicare conditions are met or exceeded, we may deem that
provider entity as having met the requirements. Accreditation by an AO
is voluntary and is not required for Medicare participation.
If an AO is recognized by the Secretary of the Department of Health
and Human Services as having standards for accreditation that meet or
exceed Medicare requirements, any provider entity accredited by the
national accrediting body's approved program may be deemed to meet the
Medicare conditions. The AO applying for approval of its accreditation
program under part 488, subpart A, must provide CMS with reasonable
assurance that the AO requires the accredited provider entities to meet
requirements that are at least as stringent as the Medicare conditions.
Our regulations concerning the approval of AOs are set forth at Sec.
488.5.
The QUAD A's current term of approval for its OPT program expires
April 4, 2025.
II. Approval of Deeming Organization
Section 1865(a)(2) of the Act and our regulations at Sec. 488.5
require that our findings concerning review and approval of an AO's
requirements consider, among other factors, the applying AO's
requirements for accreditation; survey procedures; resources for
conducting required surveys; capacity to furnish information for use in
enforcement activities; monitoring procedures for provider entities
found not in compliance with the conditions or requirements; and
ability to provide CMS with the necessary data for validation.
Section 1865(a)(3)(A) of the Act further requires that we publish,
within 60 days of receipt of an organization's complete application, a
notice that identifies the national accrediting body making the
request, describes the nature of the request, and provides at least a
30-day public comment period. We have 210 days from the receipt of a
complete application to publish notice of approval or denial of the
application.
The purpose of this proposed notice is to inform the public of QUAD
A's request for continued CMS-approval of its OPT accreditation
program. This notice also solicits public comment on whether QUAD A's
requirements meet or exceed the Medicare conditions for participation
(CoPs) for OPTs.
III. Evaluation of Deeming Authority Request
QUAD A submitted all the necessary materials to enable us to make a
determination concerning its request for continued CMS-approval of its
OPT accreditation program. This application was determined to be
complete on September 9, 2024. Under section 1865(a)(2) of the Act and
Sec. 488.5, our review and evaluation of QUAD A will be conducted in
accordance with, but not necessarily limited to, the following factors:
The equivalency of QUAD A's standards for OPTs as compared
with Medicare's CoPs for OPTs.
QUAD A's survey process to determine the following:
++ The composition of the survey team, surveyor qualifications, and
the ability of the organization to provide continuing surveyor
training.
++ The comparability of QUAD A's processes to those of State
agencies, including survey frequency, and the ability to investigate
and respond appropriately to complaints against accredited facilities.
++ QUAD A's processes and procedures for monitoring an OPT found
out of compliance with QUAD A's program requirements. These monitoring
procedures are used only when QUAD A identifies noncompliance. If
noncompliance is identified through validation reviews or complaint
surveys, the State survey agency monitors corrections as specified at
Sec. 488.9(c)(1).
++ QUAD A's capacity to report deficiencies to the surveyed
facilities and respond to the facility's plan of correction in a timely
manner.
++ QUAD A's capacity to provide CMS with electronic data and
reports necessary for the effective validation and assessment of the
organization's survey process.
++ The adequacy of QUAD A's staff and other resources, and its
financial viability.
++ QUAD A's capacity to adequately fund required surveys.
++ QUAD A's policies with respect to whether surveys are announced
or unannounced, to ensure that surveys are unannounced.
++ QUAD A's policies and procedures to avoid conflicts of interest,
including the appearance of conflicts of interest, involving
individuals who conduct surveys or participate in accreditation
decisions.
[[Page 83691]]
++ QUAD A's agreement to provide CMS with a copy of the most
current accreditation survey together with any other information
related to the survey as CMS may require (including corrective action
plans).
IV. Collection of Information Requirements
This document does not impose information collection requirements,
that is, reporting, recordkeeping or third-party disclosure
requirements. Consequently, there is no need for review by the Office
of Management and Budget under the authority of the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.).
V. Response to Public Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
The Administrator of the Centers for Medicare & Medicaid Services
(CMS), Chiquita Brooks-LaSure, having reviewed and approved this
document, authorizes Vanessa Garcia, who is the Federal Register
Liaison, to electronically sign this document for purposes of
publication in the Federal Register.
Vanessa Garcia,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2024-23930 Filed 10-16-24; 8:45 am]
BILLING CODE 4120-01-P