Medicare and Medicaid Programs: Application From the Accreditation Commission for Healthcare (ACHC) for Continued CMS-Approval of Its Hospital Accreditation Program, 23088-23089 [2023-07930]
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Federal Register / Vol. 88, No. 72 / Friday, April 14, 2023 / Notices
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Consequently, there is no need for
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Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
The Administrator of CMS, Chiquita
Brooks-LaSure, having reviewed and
approved this document, authorizes
Evell J. Barco Holland, who is the
Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
Dated: April 11, 2023.
Evell J. Barco Holland,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2023–07909 Filed 4–13–23; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3438–PN]
Medicare and Medicaid Programs:
Application From the Accreditation
Commission for Healthcare (ACHC) for
Continued CMS-Approval of Its
Hospital Accreditation Program
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice with comment.
ddrumheller on DSK120RN23PROD with NOTICES1
AGENCY:
This notice acknowledges the
receipt of an application from the
Accreditation Commission for
Healthcare for continued recognition as
a national accrediting organization for
hospitals that wish to participate in the
Medicare or Medicaid programs.
SUMMARY:
VerDate Sep<11>2014
17:45 Apr 13, 2023
Jkt 259001
To be assured consideration,
comments must be received at one of
the addresses provided below, by May
15, 2023.
ADDRESSES: In commenting, please refer
to file code CMS–3438–PN.
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–3438–PN, P.O. Box 8010,
Baltimore, MD 21244–8010.
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–3438–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:
Danielle Adams, (410) 786–8818; or
Lillian Williams, (410) 786–8636.
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
individual will take actions to harm the
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.
DATES:
I. Background
Under the Medicare program, eligible
beneficiaries may receive covered
PO 00000
Frm 00093
Fmt 4703
Sfmt 4703
services from a hospital provided
certain requirements are met. Sections
1861(e) of the Social Security Act (the
Act), establish distinct criteria for
facilities seeking designation as a
hospital. Regulations concerning
provider agreements are at 42 CFR part
489 and those pertaining to activities
relating to the survey and certification
of facilities are at 42 CFR part 488. The
regulations at 42 CFR part 482 specify
the minimum conditions that a hospital
must meet to participate in the Medicare
program.
Generally, to enter into an agreement,
a hospital must first be certified by a
state survey agency (SA) as complying
with the conditions or requirements set
forth in part 482 of our regulations.
Thereafter, the hospital is subject to
regular surveys by a SA to determine
whether it continues to meet these
requirements. There is an alternative,
however, to surveys by SAs.
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 will deem those provider
entities 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 (the Secretary) as
having standards for accreditation that
meet or exceed Medicare requirements,
any provider entity accredited by the
national accrediting body’s approved
program would be deemed to meet the
Medicare conditions. A national 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 §§ 488.4, 488.5
and 488.5(e)(2)(i). The regulations at
§ 488.5(e)(2)(i) require AOs to reapply
for continued approval of its
accreditation program every 6 years or
sooner as determined by CMS.
The Accreditation Commission for
Healthcare’s (ACHC) current term of
approval for their hospital accreditation
program expires September 25, 2023.
II. Approval of Deeming Organizations
Section 1865(a)(2) of the Act and our
regulations at § 488.5 require that our
findings concerning review and
approval of a national AO’s
E:\FR\FM\14APN1.SGM
14APN1
Federal Register / Vol. 88, No. 72 / Friday, April 14, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
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
identifying the national accrediting
body making the request, describing the
nature of the request, and providing 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 notice is to inform
the public of ACHC’s request for
continued approval of its hospital
accreditation program. This notice also
solicits public comment on whether
ACHC’s requirements meet or exceed
the Medicare conditions of participation
(CoPs) for hospitals.
III. Evaluation of Deeming Authority
Request
ACHC submitted all the necessary
materials to enable us to make a
determination concerning its request for
continued approval of its hospital
accreditation program. This application
was determined to be complete on
February 27, 2023. Under section
1865(a)(2) of the Act and our regulations
at § 488.5 (Application and reapplication procedures for national
accrediting organizations), our review
and evaluation of ACHC will be
conducted in accordance with, but not
necessarily limited to, the following
factors:
• The equivalency of ACHC’s
standards for hospitals as compared
with CMS’ hospital CoPs.
• ACHC’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 ACHC’s
processes to those of state agencies,
including survey frequency, and the
ability to investigate and respond
appropriately to complaints against
accredited facilities.
++ ACHC’s processes and procedures
for monitoring a hospital found out of
compliance with ACHC’s program
requirements. These monitoring
procedures are used only when ACHC
identifies noncompliance. If
VerDate Sep<11>2014
17:45 Apr 13, 2023
Jkt 259001
noncompliance is identified through
validation reviews or complaint
surveys, the SA monitors corrections as
specified at § 488.9.
++ ACHC’s capacity to report
deficiencies to the surveyed facilities
and respond to the facility’s plan of
correction in a timely manner.
++ ACHC’s capacity to provide CMS
with electronic data and reports
necessary for effective validation and
assessment of the organization’s survey
process.
++ The adequacy of ACHC’s staff and
other resources, and its financial
viability.
++ ACHC’s capacity to adequately
fund required surveys.
++ ACHC’s policies with respect to
whether surveys are announced or
unannounced, to assure that surveys are
unannounced.
++ ACHC’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.
++ ACHC’s agreement to provide
CMS with a copy of the most current
accreditation survey together with any
other information related to the survey
as we may require (including corrective
action plans).
23089
Dated: April 11, 2023.
Evell J. Barco Holland,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2023–07930 Filed 4–13–23; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–5422]
Peripheral Percutaneous Transluminal
Angioplasty and Specialty Catheters—
Premarket Notification (510(k))
Submissions; Guidance for Industry
and Food and Drug Administration
Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
V. Response to Comments
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Peripheral
Percutaneous Transluminal Angioplasty
(PTA) and Specialty Catheters—
Premarket Notification (510(k))
Submissions.’’ FDA is issuing this final
guidance document to provide
recommendations for 510(k)
submissions for peripheral
percutaneous transluminal angioplasty
(PTA) balloons and specialty catheters
(e.g., infusion catheters, PTA balloon
catheters for in-stent restenosis (ISR),
scoring/cutting balloons).
DATES: The announcement of the
guidance is published in the Federal
Register on April 14, 2023.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
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 Evell J. Barco Holland, who
is the Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
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.).
PO 00000
Frm 00094
Fmt 4703
Sfmt 4703
SUMMARY:
E:\FR\FM\14APN1.SGM
14APN1
]]>Agencies
[Federal Register Volume 88, Number 72 (Friday, April 14, 2023)]
[Notices]
[Pages 23088-23089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07930]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3438-PN]
Medicare and Medicaid Programs: Application From the
Accreditation Commission for Healthcare (ACHC) for Continued CMS-
Approval of Its Hospital Accreditation Program
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Notice with comment.
-----------------------------------------------------------------------
SUMMARY: This notice acknowledges the receipt of an application from
the Accreditation Commission for Healthcare for continued recognition
as a national accrediting organization for hospitals 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, by May 15, 2023.
ADDRESSES: In commenting, please refer to file code CMS-3438-PN.
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-3438-PN, P.O. Box 8010,
Baltimore, MD 21244-8010.
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-3438-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: Danielle Adams, (410) 786-8818; or
Lillian Williams, (410) 786-8636.
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 individual will take actions to harm
the 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
Under the Medicare program, eligible beneficiaries may receive
covered services from a hospital provided certain requirements are met.
Sections 1861(e) of the Social Security Act (the Act), establish
distinct criteria for facilities seeking designation as a hospital.
Regulations concerning provider agreements are at 42 CFR part 489 and
those pertaining to activities relating to the survey and certification
of facilities are at 42 CFR part 488. The regulations at 42 CFR part
482 specify the minimum conditions that a hospital must meet to
participate in the Medicare program.
Generally, to enter into an agreement, a hospital must first be
certified by a state survey agency (SA) as complying with the
conditions or requirements set forth in part 482 of our regulations.
Thereafter, the hospital is subject to regular surveys by a SA to
determine whether it continues to meet these requirements. There is an
alternative, however, to surveys by SAs.
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 will deem those
provider entities 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 (the Secretary) as having standards for
accreditation that meet or exceed Medicare requirements, any provider
entity accredited by the national accrediting body's approved program
would be deemed to meet the Medicare conditions. A national 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. Sec. 488.4, 488.5 and
488.5(e)(2)(i). The regulations at Sec. 488.5(e)(2)(i) require AOs to
reapply for continued approval of its accreditation program every 6
years or sooner as determined by CMS.
The Accreditation Commission for Healthcare's (ACHC) current term
of approval for their hospital accreditation program expires September
25, 2023.
II. Approval of Deeming Organizations
Section 1865(a)(2) of the Act and our regulations at Sec. 488.5
require that our findings concerning review and approval of a national
AO's
[[Page 23089]]
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 identifying the national accrediting body making the request,
describing the nature of the request, and providing 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 notice is to inform the public of ACHC's
request for continued approval of its hospital accreditation program.
This notice also solicits public comment on whether ACHC's requirements
meet or exceed the Medicare conditions of participation (CoPs) for
hospitals.
III. Evaluation of Deeming Authority Request
ACHC submitted all the necessary materials to enable us to make a
determination concerning its request for continued approval of its
hospital accreditation program. This application was determined to be
complete on February 27, 2023. Under section 1865(a)(2) of the Act and
our regulations at Sec. 488.5 (Application and re-application
procedures for national accrediting organizations), our review and
evaluation of ACHC will be conducted in accordance with, but not
necessarily limited to, the following factors:
The equivalency of ACHC's standards for hospitals as
compared with CMS' hospital CoPs.
ACHC'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 ACHC's processes to those of state
agencies, including survey frequency, and the ability to investigate
and respond appropriately to complaints against accredited facilities.
++ ACHC's processes and procedures for monitoring a hospital found
out of compliance with ACHC's program requirements. These monitoring
procedures are used only when ACHC identifies noncompliance. If
noncompliance is identified through validation reviews or complaint
surveys, the SA monitors corrections as specified at Sec. 488.9.
++ ACHC's capacity to report deficiencies to the surveyed
facilities and respond to the facility's plan of correction in a timely
manner.
++ ACHC's capacity to provide CMS with electronic data and reports
necessary for effective validation and assessment of the organization's
survey process.
++ The adequacy of ACHC's staff and other resources, and its
financial viability.
++ ACHC's capacity to adequately fund required surveys.
++ ACHC's policies with respect to whether surveys are announced or
unannounced, to assure that surveys are unannounced.
++ ACHC'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.
++ ACHC's agreement to provide CMS with a copy of the most current
accreditation survey together with any other information related to the
survey as we 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 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 Evell J. Barco Holland, who is the Federal
Register Liaison, to electronically sign this document for purposes of
publication in the Federal Register.
Dated: April 11, 2023.
Evell J. Barco Holland,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2023-07930 Filed 4-13-23; 8:45 am]
BILLING CODE 4120-01-P
