Medicare and Medicaid Programs: Application by the Community Health Accreditation Partner (CHAP) Inc. for Continued CMS-Approval of Its Hospice Accreditation Program, 48646-48647 [2024-12495]
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48646
Federal Register / Vol. 89, No. 111 / Friday, June 7, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
performance of the Board’s functions,
including whether the information has
practical utility;
b. The accuracy of the Board’s
estimate of the burden of the proposed
information collection, including the
validity of the methodology and
assumptions used;
c. Ways to enhance the quality,
utility, and clarity of the information to
be collected;
d. Ways to minimize the burden of
information collection on respondents,
including through the use of automated
collection techniques or other forms of
information technology; and
e. Estimates of capital or startup costs
and costs of operation, maintenance,
and purchase of services to provide
information.
At the end of the comment period, the
comments and recommendations
received will be analyzed to determine
the extent to which the Board should
modify the proposal.
Proposal Under OMB Delegated
Authority To Extend for Three Years,
Without Revision, the Following
Information Collection
Collection title: Recordkeeping and
Disclosure Requirements Associated
with CFPB’s Regulation Z.
Collection identifier: FR Z.
OMB control number: 7100–0199.
General description of collection: The
Truth in Lending Act (TILA) and
Regulation Z require creditors to
provide consumers with disclosures
about the costs, terms, and related
information regarding a wide range of
credit products for personal, family, or
household purposes. Depending on the
credit product, required disclosures
include information that must be
provided at the time of the consumer’s
application for credit, at consummation
(for closed-end credit) or accountopening (for open-end credit), and
throughout the term of the loan. The
TILA and Regulation Z also contain
rules concerning recordkeeping and
credit advertising.
The FR Z is the Board’s information
collection associated with the Consumer
Financial Protection Bureau’s (CFPB’s)
Regulation Z. FR Z is used to promote
the informed use of credit by consumers
for personal, family, or household
purposes by requiring these disclosures
about the terms and costs of these
products, as well as ensuring that
consumers are provided with timely
information on the nature and costs of
the residential real estate settlement
process.
Frequency: Event-generated.
Respondents: State member banks
with assets of $10 billion or less that are
VerDate Sep<11>2014
17:23 Jun 06, 2024
Jkt 262001
not affiliated with an insured depository
institution with assets over $10 billion
(irrespective of the consolidated assets
of any holding company); nondepository affiliates of such state
member banks; and non-depository
affiliates of bank holding companies
that are not affiliated with an insured
depository institution with assets over
$10 billion.
Total estimated number of
respondents: 3,695.
Total estimated annual burden hours:
387,079.
Board of Governors of the Federal Reserve
System, June 4, 2024.
Benjamin W. McDonough,
Deputy Secretary and Ombuds of the Board.
[FR Doc. 2024–12500 Filed 6–6–24; 8:45 am]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3457–PN]
Medicare and Medicaid Programs:
Application by the Community Health
Accreditation Partner (CHAP) Inc. for
Continued CMS-Approval of Its
Hospice 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
Community Health Accreditation
Partner for continued recognition as a
national accrediting organization for
hospices 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 July 8, 2024.
ADDRESSES: In commenting, refer to file
code CMS–3457–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–3457–PN, P.O. Box 8016,
Baltimore, MD 21244–8010.
SUMMARY:
PO 00000
Frm 00097
Fmt 4703
Sfmt 4703
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–3457–PN,
Mail Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
Submission of comments on
paperwork requirements. You may
submit comments on this document’s
paperwork requirements by following
the instructions at the end of the
‘‘Collection of Information
Requirements’’ section in this
document. For information on viewing
public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Lillian Williams, (410) 786–8636.
Erin Imhoff, (410) 786–2337.
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.
I. Background
Under the Medicare program, eligible
beneficiaries may receive covered
services in a hospice, provided that
certain requirements are met by the
hospice. Section 1861(dd) of the Social
Security Act (the Act) establishes
distinct criteria for facilities seeking
designation as a hospice. 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
418 specify the conditions that a
hospice must meet in order to
participate in the Medicare program, the
scope of covered services and the
conditions for Medicare payment for
hospice services.
Generally, to enter into an agreement,
a hospice must first be certified by a
State survey agency (SA) as complying
with the conditions or requirements set
forth in part 418. Thereafter, the hospice
is subject to regular surveys by a State
survey agency to determine whether it
continues to meet these requirements.
E:\FR\FM\07JNN1.SGM
07JNN1
Federal Register / Vol. 89, No. 111 / Friday, June 7, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
However, 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 and
488.5. 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.
Community Health Accreditation
Partner’s (CHAP’s) current term of
approval for their hospice accreditation
program expires February 24, 2025.
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
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 proposed notice
is to inform the public of the CHAP
VerDate Sep<11>2014
17:23 Jun 06, 2024
Jkt 262001
request for continued approval of its
hospice accreditation program. This
notice also solicits public comment on
whether the CHAP’s requirements meet
or exceed the Medicare conditions of
participation (CoPs) for hospices.
III. Evaluation of Deeming Authority
Request
CHAP submitted all the necessary
materials to enable us to make a
determination concerning its request for
continued approval of its hospice
accreditation program. This application
was determined to be complete on April
20, 2024. Under section 1865(a)(2) of the
Act and our regulations at § 488.5
(Application and re-application
procedures for national AO) our review
and evaluation of CHAP will be
conducted in accordance with, but not
necessarily limited to, the following
factors:
• The equivalency of CHAP’s
standards for hospices as compared
with CMS’ hospice CoPs.
• CHAP’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 CHAP’s
processes to those of state agencies,
including survey frequency, and the
ability to investigate and respond
appropriately to complaints against
accredited facilities.
++ CHAP’s processes and procedures
for monitoring hospices, which are
found out of compliance with CHAP’s
program requirements. These
monitoring procedures are used only
when CHAP identifies noncompliance.
If noncompliance is identified through
validation reviews or complaint
surveys, the SA monitors corrections as
specified at § 488.9.
++ CHAP’s capacity to report
deficiencies to the surveyed facilities
and respond to the facility’s plan of
correction in a timely manner.
++ CHAP’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 CHAP’s staff and
other resources, and its financial
viability.
++ CHAP’s capacity to adequately
fund required surveys.
++ CHAP’s policies with respect to
whether surveys are announced or
unannounced, to ensure that surveys are
unannounced.
++ CHAP’s policies and procedures
to avoid conflicts of interest, including
the appearance of conflicts of interest,
PO 00000
Frm 00098
Fmt 4703
Sfmt 4703
48647
involving individuals who conduct
surveys or participate in accreditation
decisions.
++ CHAP’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 Vanessa Garcia, who is the
Federal Register Liaison, to
electronically sign this document
forpurposes of publication in the
Federal Register.
Vanessa Garcia,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2024–12495 Filed 6–6–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–2390]
Proposal To Refuse To Approve a New
Drug Application Supplement for
HETLIOZ (Tasimelteon); Opportunity
for a Hearing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Director of the Center for
Drug Evaluation and Research (Center
Director) at the Food and Drug
Administration (FDA or Agency) is
SUMMARY:
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Agencies
[Federal Register Volume 89, Number 111 (Friday, June 7, 2024)]
[Notices]
[Pages 48646-48647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12495]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3457-PN]
Medicare and Medicaid Programs: Application by the Community
Health Accreditation Partner (CHAP) Inc. for Continued CMS-Approval of
Its Hospice 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 Community Health Accreditation Partner for continued recognition as
a national accrediting organization for hospices 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 July 8, 2024.
ADDRESSES: In commenting, refer to file code CMS-3457-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-3457-PN, P.O. Box 8016,
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-3457-PN, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
Submission of comments on paperwork requirements. You may submit
comments on this document's paperwork requirements by following the
instructions at the end of the ``Collection of Information
Requirements'' section in this document. For information on viewing
public comments, see the beginning of the SUPPLEMENTARY INFORMATION
section.
FOR FURTHER INFORMATION CONTACT:
Lillian Williams, (410) 786-8636.
Erin Imhoff, (410) 786-2337.
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.
I. Background
Under the Medicare program, eligible beneficiaries may receive
covered services in a hospice, provided that certain requirements are
met by the hospice. Section 1861(dd) of the Social Security Act (the
Act) establishes distinct criteria for facilities seeking designation
as a hospice. 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 418 specify the conditions that a hospice must meet in
order to participate in the Medicare program, the scope of covered
services and the conditions for Medicare payment for hospice services.
Generally, to enter into an agreement, a hospice must first be
certified by a State survey agency (SA) as complying with the
conditions or requirements set forth in part 418. Thereafter, the
hospice is subject to regular surveys by a State survey agency to
determine whether it continues to meet these requirements.
[[Page 48647]]
However, 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 and 488.5. 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.
Community Health Accreditation Partner's (CHAP's) current term of
approval for their hospice accreditation program expires February 24,
2025.
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 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 proposed notice is to inform the public of the
CHAP request for continued approval of its hospice accreditation
program. This notice also solicits public comment on whether the CHAP's
requirements meet or exceed the Medicare conditions of participation
(CoPs) for hospices.
III. Evaluation of Deeming Authority Request
CHAP submitted all the necessary materials to enable us to make a
determination concerning its request for continued approval of its
hospice accreditation program. This application was determined to be
complete on April 20, 2024. Under section 1865(a)(2) of the Act and our
regulations at Sec. 488.5 (Application and re-application procedures
for national AO) our review and evaluation of CHAP will be conducted in
accordance with, but not necessarily limited to, the following factors:
The equivalency of CHAP's standards for hospices as
compared with CMS' hospice CoPs.
CHAP'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 CHAP's processes to those of state
agencies, including survey frequency, and the ability to investigate
and respond appropriately to complaints against accredited facilities.
++ CHAP's processes and procedures for monitoring hospices, which
are found out of compliance with CHAP's program requirements. These
monitoring procedures are used only when CHAP identifies noncompliance.
If noncompliance is identified through validation reviews or complaint
surveys, the SA monitors corrections as specified at Sec. 488.9.
++ CHAP's capacity to report deficiencies to the surveyed
facilities and respond to the facility's plan of correction in a timely
manner.
++ CHAP'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 CHAP's staff and other resources, and its
financial viability.
++ CHAP's capacity to adequately fund required surveys.
++ CHAP's policies with respect to whether surveys are announced or
unannounced, to ensure that surveys are unannounced.
++ CHAP'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.
++ CHAP'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 Vanessa Garcia, who is the Federal Register
Liaison, to electronically sign this document forpurposes of
publication in the Federal Register.
Vanessa Garcia,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2024-12495 Filed 6-6-24; 8:45 am]
BILLING CODE 4120-01-P