Agency Information Collection Activities: Submission for OMB Review; Comment Request, 83015-83017 [2024-23737]
Download as PDF
<![CDATA[
Federal Register / Vol. 89, No. 199 / Tuesday, October 15, 2024 / Notices
Board of Governors of the Federal Reserve
System.
Michele Taylor Fennell,
Associate Secretary of the Board.
[FR Doc. 2024–23784 Filed 10–11–24; 8:45 am]
BILLING CODE 6210–01–P
FEDERAL RETIREMENT THRIFT
INVESTMENT BOARD
Notice of Board Meeting
October 22, 2024 at 10 a.m.
eastern daylight time (EDT).
ADDRESSES: Telephonic. Dial-in (listen
only) information: Number: 1–202–599–
1426, Code: 828 801 968 #; or via web:
https://www.frtib.gov/.
FOR FURTHER INFORMATION CONTACT:
Kimberly Weaver, Director, Office of
External Affairs, (202) 942–1640.
SUPPLEMENTARY INFORMATION: BOARD
MEETING AGENDA.
DATES:
Open Session
1. Approval of the September 24, 2024,
Board Meeting Minutes
2. Monthly Reports
(a) Participant Report
(b) Legislative Report
3. Quarterly Reports
(c) Investment Review
(d) Audit Status
(e) Budget Review
4. Internal Audit Update
5. OEA Annual Presentation
6. Social Science Update
Closed Session
7. Information covered under 5 U.S.C.
552b(c)(6), (c)(9)(B), and (c)(10).
Authority: 5 U.S.C. 552b(e)(1).
Dated: October 9, 2024.
Dharmesh Vashee,
General Counsel, Federal Retirement Thrift
Investment Board.
[FR Doc. 2024–23779 Filed 10–11–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
khammond on DSKJM1Z7X2PROD with NOTICES
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
18:13 Oct 11, 2024
Jkt 265001
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, please access the CMS PRA
website by copying and pasting the
following web address into your web
browser: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.
ADDRESSES:
William Parham at (410) 786–4669.
Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
SUPPLEMENTARY INFORMATION:
[Document Identifier: CMS–855B, CMS–R–
48 and CMS–10239]
VerDate Sep<11>2014
Comments on the collection(s) of
information must be received by the
OMB desk officer by November 14,
2024.
DATES:
FOR FURTHER INFORMATION CONTACT:
Centers for Medicare & Medicaid
Services
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including the necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected, and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
SUMMARY:
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
83015
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires Federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Reinstatement with change of a
previously approved collection; Title of
Information Collection: Medicare
Enrollment Application for Clinics/
Group Practices and Other Suppliers;
Use: Various sections of the Act, the
United States Code (U.S.C.), Internal
Revenue Service (IRS) Code, and the
CFR require providers and suppliers to
furnish information concerning the
amounts due and the identification of
individuals or entities that furnish
medical services to beneficiaries before
payment can be made. The Form CMS–
855B application is submitted when the
applicant first requests Medicare
enrollment. The application is used by
the MACs to collect data to ensure the
applicant has the necessary credentials
to provide the health care services for
which they intend to bill Medicare; this
includes data that allows the Medicare
contractor to correctly price, process,
and pay the applicant’s claims. It also
gathers information that enables MACs
to ensure that the supplier is neither
excluded from the Medicare program
nor debarred, suspended, or excluded
from any other Federal agency or
program. The application is also used by
enrolled suppliers when they are
reporting a change in their ownership,
a change in their current Medicare
enrollment information, or are
revalidating or reactivating their
Medicare enrollment. Form Number:
CMS–855B (OMB control number:
0938–1377); Frequency: Occasionally;
Affected Public: Private Sector; Business
or other for-profits, and Not-for Profits;
Number of Respondents: 132,800;
Number of Responses: 132,800; Total
Annual Hours: 155,884. (For questions
regarding this collection, contact Frank
Whalen at 410–786–1302 or
Frank.Whelan@cms.hhs.gov.)
1. Type of Information Collection
Request: Reinstatement with change of a
previously approved collection; Title of
Information Collection: Hospital
Conditions of Participation (CoPs) and
Supporting Regulations; Use: The
purpose of this package is to request
from the Office of Management and
Budget (OMB) approval of the
E:\FR\FM\15OCN1.SGM
15OCN1
khammond on DSKJM1Z7X2PROD with NOTICES
83016
Federal Register / Vol. 89, No. 199 / Tuesday, October 15, 2024 / Notices
reinstatement with change of the
information collection request
associated with OMB control number:
0938–0328.
The information collection
requirements described herein are
needed to implement the Medicare and
Medicaid Conditions of Participation
(CoPs) for a total of 5,132 facilities that
includes: 4,994 accredited and nonaccredited hospitals and 138 Critical
Access Hospitals (CAHs) with Distinct
Part Units (DPUs); specifically, 119
CAHs with psychiatric DPUs and 19
CAHs with rehabilitation DPUs. The
information collection requirements for
the 1,245 CAHs without DPUs (1,383
total CAHs less 138 CAHs with DPUs)
are covered under OMB control number:
0938–1043 (CMS–10239).
As previous stated, this notice is
related to a reinstatement of the
information collection request that
expired on 11/30/2017. The previous
iteration of this OMB control number
0938–0328 (approved November 14,
2014) had a burden of 14,424,655
annual hours. For this requested
reinstatement, with changes, the
adjusted annual hourly burden for
industry is 3,566,521 hours at an annual
cost of $310,989,894. The decrease in
burden hours is primarily due to the fact
that many of the information collections
that were previously required as CoPs
by CMS are now customary and usual
industry practice and would take place
in the absence of the Medicare and
Medicaid programs. In addition, where
possible, CMS reduced the burden of
CoPs with prior information collections.
For example, the burden for individual
hospitals that are part of a multihospital system was reduced by
allowing a multi-hospital system, which
represent approximately 70% of
hospitals today, to develop a unified
Quality Assessment and Performance
Improvement (QAPI) program rather
than requiring each hospital in the
system to maintain separate programs
and reporting requirements.
This reinstatement also reflects a
change in how the annual burden costs
for information collection requirements
for Hospital CoPs are calculated. In
prior submissions, the fully loaded wage
estimates applied only an additional
33% to the hourly wage to account for
fringe benefits. This reinstatement
applies an additional 100% to the
median hourly wage to reflect the costs
more accurately to hospitals for
compliance with the current CoPs.
Additional changes reflected in this
reinstatement are some of the
information collections were placed on
participating hospitals as CoPs during
the recent COVID–19 Public Health
VerDate Sep<11>2014
16:35 Oct 11, 2024
Jkt 265001
Emergency (PHE), specifically regarding
collecting and reporting data on
incidents and hospital management of
infection diseases. The burden of many
of these information collections were
accounted for in other OMB
submissions, such as the ‘‘Unified
Hospital Data Surveillance System (U.S.
Healthcare COVID–19 Collection’’ (OMB
control number 0990–0478), and some
of these collections ended or were
revised after HHS declared the end of
the COVID–19 PHE in April 2024. As a
result, this reinstatement does not
include information collection
requirements that have expired, and
only includes the annual burden and
costs to participating hospitals and
CAHs with DPUs for information
collections that have remained as CoPs
after the COVID–19 PHE ended. In
addition, in anticipation of an upcoming
final rule titled ‘‘Medicare and Medicaid
Programs and the Children’s Health
Insurance Program; Hospital Inpatient
Prospective Payment Systems for Acute
Care Hospitals and the Long-Term Care
Hospital Prospective Payment System
and Policy Changes and Fiscal Year
2025 Rates; Quality Programs
Requirements; and Other Policy
Changes,’’ this package includes burden
estimates for additional information
collection requirements that CMS is
adding as CoPs in the interest of public
health and ensuring resiliency in the
U.S. health care system. The
aforementioned final rule, CMS–1808–F
(RIN 0938–AV34), is currently on public
display at the Office of the Federal
Register and scheduled for publication
on August 28, 2024.
Finally, this reinstatement
incorporates additional information
collection requirements associated with
a number of new CoPs for hospitals and
CAHs regarding obstetrical services
which are outlined in detail in the July
2024 proposed rule titled ‘‘Medicare
and Medicaid Programs: Hospital
Outpatient Prospective Payment and
Ambulatory Surgical Center Payment
Systems; Quality Reporting Programs,
Including the Hospital Inpatient Quality
Reporting Program; Health and Safety
Standards for Obstetrical Services in
Hospitals and Critical Access Hospitals;
Prior Authorization; Requests for
Information; Medicaid and CHIP
Continuous Eligibility; Medicaid Clinic
Services Four Walls Exceptions;
Individuals Currently or Formerly in
Custody of Penal Authorities; Revision
to Medicare Special Enrollment Period
for Formerly Incarcerated Individuals;
and All-Inclusive Rate Add-On Payment
for High-Cost Drugs Provided by Indian
Health Service and Tribal Facilities’’ (89
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
FR 59186). Form Number: CMS–R–48
(OMB control number: 0938–0328);
Frequency: Yearly; Affected Public:
Private Sector (Business or other forprofit); Number of Respondents: 4,664;
Total Annual Responses: 2,647,647;
Total Annual Hours: 3,566,521 (For
policy questions regarding this
collection contact Claudia Molinar at
410–786–8445).
3. Type of Information Collection
Request: Reinstatement with change of a
previously approved collection; Title of
Information Collection: Conditions of
Participation for Critical Access
Hospitals (CAH) and Supporting
Regulations; Use: The purpose of this
package is to request from the Office of
Management and Budget (OMB) the
approval to reinstate, with changes, the
information collection request,
associated with OMB Control Number
0938–1043, titled ‘‘Critical Access
Hospital (CAH) Conditions of
Participation (CoPs) and Supporting
Regulations.’’
Sections 1820 and 1861(mm) of the
Social Security Act provide that CAHs
participating Medicare meet certain
specified requirements. The regulations
containing the information collection
requirements are located at 42 CFR part
485, subpart F. These regulations
implement sections 1102, 1138,
1814(a)(8), 1820(a–f), 1861(mm), 1864,
and 1871 of the Act.
This is a reinstatement of the
information collection request that
expired on March 31, 2024. The
previous iteration of this OMB No.
0938–1043 (approved March 25, 2021)
had a burden of 33,905 annual hours.
For this requested reinstatement, with
changes, the estimated total annual
burden hours for the industry is 898,332
hours and the estimated annual burden
costs are $74,020,673.
The increase in burden hours from the
prior package is primarily due to new
information collections associated with
new CoPs for CAHs outlined in the two
CMS rules referenced below. The new
CoPs include multiple information
collection requirements that are onetime burdens for developing new
policies and protocols and ongoing
reporting requirements, such as daily or
biweekly reporting of respiratory
illnesses as well as maternal deaths. The
reasons for the increased information
collections are discussed in more detail
in the rules and are summarized in the
information collection request.
(1) Obstetrical services included in
the proposed rule, Medicare and
Medicaid Programs: Hospital Outpatient
Prospective Payment and Ambulatory
Surgical Center Payment Systems;
Quality Reporting Programs, Including
E:\FR\FM\15OCN1.SGM
15OCN1
Federal Register / Vol. 89, No. 199 / Tuesday, October 15, 2024 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
the Hospital Inpatient Quality Reporting
Program; Health and Safety Standards
for Obstetrical Services in Hospitals and
Critical Access Hospitals; Prior
Authorization; Requests for Information;
Medicaid and CHIP Continuous
Eligibility; Medicaid Clinic Services
Four Walls Exceptions; Individuals
Currently or Formerly in Custody of
Penal Authorities; Revision to Medicare
Special Enrollment Period for Formerly
Incarcerated Individuals; and AllInclusive Rate Add-On Payment for
High-Cost Drugs Provided by Indian
Health Service and Tribal Facilities, 89
FR 59186 (July 22, 2024) (hereinafter
referred to as the ‘‘July 2024 Proposed
Rule’’).
(2) Reporting of acute respiratory
illnesses in the interest of public health
and ensuring resiliency in the U.S.
health care system included in the Final
rule: Medicare and Medicaid Programs
and the Children’s Health Insurance
Program; Hospital Inpatient Prospective
Payment Systems for Acute Care
Hospitals and the Long-Term Care
Hospital Prospective Payment System
and Policy Changes and Fiscal Year
2025 Rates; Quality Programs
Requirements; and Other Policy
Changes. The aforementioned final rule,
CMS–1808–F (RIN 0938–AV34), is
currently on display at the Office of the
Federal Register and scheduled for
publication on August 28, 2024
(hereinafter referred to as the ‘‘August
2024 Final Rule’’).
The change in total burden hours is
also due to prior information collection
requests are exempt from the PRA
because the requirements are customary
and usual industry practice and would
take place in the absence of the
Medicare and Medicaid programs. Form
Number: CMS–10239 (OMB control
number: 0938–1043); Frequency: Yearly;
Affected Public: Private Sector (Business
or other for-profit); Number of
Respondents: 1,245; Total Annual
Responses: 9,145; Total Annual Hours:
898,332 (For policy questions regarding
this collection contact Claudia Molinar
at 410–786–8445).
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–23737 Filed 10–11–24; 8:45 am]
BILLING CODE 4120–01–P
VerDate Sep<11>2014
16:35 Oct 11, 2024
Jkt 265001
83017
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: October 8, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
Food and Drug Administration
[FR Doc. 2024–23651 Filed 10–11–24; 8:45 am]
BILLING CODE 4164–01–P
[Docket No. FDA–2018–N–1262]
Notice of Approval of Product Under
Voucher: Rare Pediatric Disease
Priority Review Voucher; KISQALI
(ribociclib)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of approval of a product
redeeming a priority review voucher.
The Federal Food, Drug, and Cosmetic
Act (FD&C Act) authorizes FDA to
award priority review vouchers to
sponsors of approved rare pediatric
disease product applications that meet
certain criteria. FDA is required to
publish notice of the issuance of priority
review vouchers as well as the approval
of products redeeming a priority review
voucher. FDA has determined that the
supplemental application for KISQALI
(ribociclib), approved September 17,
2024, meets the criteria for redeeming a
priority review voucher.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Cathryn Lee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–1394, email: Cathryn.Lee@
fda.hhs.gov.
FDA is
announcing the approval of a product
redeeming a rare pediatric disease
priority review voucher. Under section
529 of the FD&C Act (21 U.S.C. 360ff),
FDA will report the issuance of rare
pediatric disease priority review
vouchers and the approval of products
for which a voucher was redeemed.
FDA has determined that the
supplemental application (Supplement18) for KISQALI (ribociclib) meets the
redemption criteria.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about KISQALI
(ribociclib), go to the ‘‘Drugs@FDA’’
website at https://www.accessdata.
fda.gov/scripts/cder/daf/.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–D–4095]
Using Relative Supersaturation To
Support ‘Urinary Tract Health’ Claims
for Adult Maintenance Cat Food;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of a final
guidance for industry #284 entitled
‘‘Using Relative Supersaturation To
Support ‘Urinary Tract Health’ Claims
for Adult Maintenance Cat Food.’’
FDA’s Center for Veterinary Medicine
(CVM) has evaluated the use of relative
supersaturation (RSS) methodology to
support urinary tract health claims for
certain adult maintenance cat food. RSS
is a measurement that estimates the
potential for crystal formation and
bladder stone growth, which is a
common affliction in cats. This
guidance provides recommendations for
how pet food manufacturers can use
RSS methodology to substantiate
general structure or function claims that
an adult maintenance cat food supports
urinary tract health by promoting a
healthy mineral content in the urinary
tract.
DATES: The announcement of the
guidance is published in the Federal
Register on October 15, 2024.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
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,
E:\FR\FM\15OCN1.SGM
15OCN1
]]>Agencies
[Federal Register Volume 89, Number 199 (Tuesday, October 15, 2024)]
[Notices]
[Pages 83015-83017]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23737]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-855B, CMS-R-48 and CMS-10239]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. Under the Paperwork Reduction
Act of 1995 (PRA), Federal agencies are required to publish notice in
the Federal Register concerning each proposed collection of
information, including each proposed extension or reinstatement of an
existing collection of information, and to allow a second opportunity
for public comment on the notice. Interested persons are invited to
send comments regarding the burden estimate or any other aspect of this
collection of information, including the necessity and utility of the
proposed information collection for the proper performance of the
agency's functions, the accuracy of the estimated burden, ways to
enhance the quality, utility, and clarity of the information to be
collected, and the use of automated collection techniques or other
forms of information technology to minimize the information collection
burden.
DATES: Comments on the collection(s) of information must be received by
the OMB desk officer by November 14, 2024.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, please access
the CMS PRA website by copying and pasting the following web address
into your web browser: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.
FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. The term ``collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and
includes agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires
Federal agencies to publish a 30-day notice in the Federal Register
concerning each proposed collection of information, including each
proposed extension or reinstatement of an existing collection of
information, before submitting the collection to OMB for approval. To
comply with this requirement, CMS is publishing this notice that
summarizes the following proposed collection(s) of information for
public comment:
1. Type of Information Collection Request: Reinstatement with
change of a previously approved collection; Title of Information
Collection: Medicare Enrollment Application for Clinics/Group Practices
and Other Suppliers; Use: Various sections of the Act, the United
States Code (U.S.C.), Internal Revenue Service (IRS) Code, and the CFR
require providers and suppliers to furnish information concerning the
amounts due and the identification of individuals or entities that
furnish medical services to beneficiaries before payment can be made.
The Form CMS-855B application is submitted when the applicant first
requests Medicare enrollment. The application is used by the MACs to
collect data to ensure the applicant has the necessary credentials to
provide the health care services for which they intend to bill
Medicare; this includes data that allows the Medicare contractor to
correctly price, process, and pay the applicant's claims. It also
gathers information that enables MACs to ensure that the supplier is
neither excluded from the Medicare program nor debarred, suspended, or
excluded from any other Federal agency or program. The application is
also used by enrolled suppliers when they are reporting a change in
their ownership, a change in their current Medicare enrollment
information, or are revalidating or reactivating their Medicare
enrollment. Form Number: CMS-855B (OMB control number: 0938-1377);
Frequency: Occasionally; Affected Public: Private Sector; Business or
other for-profits, and Not-for Profits; Number of Respondents: 132,800;
Number of Responses: 132,800; Total Annual Hours: 155,884. (For
questions regarding this collection, contact Frank Whalen at 410-786-
1302 or [email protected].)
1. Type of Information Collection Request: Reinstatement with
change of a previously approved collection; Title of Information
Collection: Hospital Conditions of Participation (CoPs) and Supporting
Regulations; Use: The purpose of this package is to request from the
Office of Management and Budget (OMB) approval of the
[[Page 83016]]
reinstatement with change of the information collection request
associated with OMB control number: 0938-0328.
The information collection requirements described herein are needed
to implement the Medicare and Medicaid Conditions of Participation
(CoPs) for a total of 5,132 facilities that includes: 4,994 accredited
and non-accredited hospitals and 138 Critical Access Hospitals (CAHs)
with Distinct Part Units (DPUs); specifically, 119 CAHs with
psychiatric DPUs and 19 CAHs with rehabilitation DPUs. The information
collection requirements for the 1,245 CAHs without DPUs (1,383 total
CAHs less 138 CAHs with DPUs) are covered under OMB control number:
0938-1043 (CMS-10239).
As previous stated, this notice is related to a reinstatement of
the information collection request that expired on 11/30/2017. The
previous iteration of this OMB control number 0938-0328 (approved
November 14, 2014) had a burden of 14,424,655 annual hours. For this
requested reinstatement, with changes, the adjusted annual hourly
burden for industry is 3,566,521 hours at an annual cost of
$310,989,894. The decrease in burden hours is primarily due to the fact
that many of the information collections that were previously required
as CoPs by CMS are now customary and usual industry practice and would
take place in the absence of the Medicare and Medicaid programs. In
addition, where possible, CMS reduced the burden of CoPs with prior
information collections. For example, the burden for individual
hospitals that are part of a multi-hospital system was reduced by
allowing a multi-hospital system, which represent approximately 70% of
hospitals today, to develop a unified Quality Assessment and
Performance Improvement (QAPI) program rather than requiring each
hospital in the system to maintain separate programs and reporting
requirements.
This reinstatement also reflects a change in how the annual burden
costs for information collection requirements for Hospital CoPs are
calculated. In prior submissions, the fully loaded wage estimates
applied only an additional 33% to the hourly wage to account for fringe
benefits. This reinstatement applies an additional 100% to the median
hourly wage to reflect the costs more accurately to hospitals for
compliance with the current CoPs.
Additional changes reflected in this reinstatement are some of the
information collections were placed on participating hospitals as CoPs
during the recent COVID-19 Public Health Emergency (PHE), specifically
regarding collecting and reporting data on incidents and hospital
management of infection diseases. The burden of many of these
information collections were accounted for in other OMB submissions,
such as the ``Unified Hospital Data Surveillance System (U.S.
Healthcare COVID-19 Collection'' (OMB control number 0990-0478), and
some of these collections ended or were revised after HHS declared the
end of the COVID-19 PHE in April 2024. As a result, this reinstatement
does not include information collection requirements that have expired,
and only includes the annual burden and costs to participating
hospitals and CAHs with DPUs for information collections that have
remained as CoPs after the COVID-19 PHE ended. In addition, in
anticipation of an upcoming final rule titled ``Medicare and Medicaid
Programs and the Children's Health Insurance Program; Hospital
Inpatient Prospective Payment Systems for Acute Care Hospitals and the
Long-Term Care Hospital Prospective Payment System and Policy Changes
and Fiscal Year 2025 Rates; Quality Programs Requirements; and Other
Policy Changes,'' this package includes burden estimates for additional
information collection requirements that CMS is adding as CoPs in the
interest of public health and ensuring resiliency in the U.S. health
care system. The aforementioned final rule, CMS-1808-F (RIN 0938-AV34),
is currently on public display at the Office of the Federal Register
and scheduled for publication on August 28, 2024.
Finally, this reinstatement incorporates additional information
collection requirements associated with a number of new CoPs for
hospitals and CAHs regarding obstetrical services which are outlined in
detail in the July 2024 proposed rule titled ``Medicare and Medicaid
Programs: Hospital Outpatient Prospective Payment and Ambulatory
Surgical Center Payment Systems; Quality Reporting Programs, Including
the Hospital Inpatient Quality Reporting Program; Health and Safety
Standards for Obstetrical Services in Hospitals and Critical Access
Hospitals; Prior Authorization; Requests for Information; Medicaid and
CHIP Continuous Eligibility; Medicaid Clinic Services Four Walls
Exceptions; Individuals Currently or Formerly in Custody of Penal
Authorities; Revision to Medicare Special Enrollment Period for
Formerly Incarcerated Individuals; and All-Inclusive Rate Add-On
Payment for High-Cost Drugs Provided by Indian Health Service and
Tribal Facilities'' (89 FR 59186). Form Number: CMS-R-48 (OMB control
number: 0938-0328); Frequency: Yearly; Affected Public: Private Sector
(Business or other for-profit); Number of Respondents: 4,664; Total
Annual Responses: 2,647,647; Total Annual Hours: 3,566,521 (For policy
questions regarding this collection contact Claudia Molinar at 410-786-
8445).
3. Type of Information Collection Request: Reinstatement with
change of a previously approved collection; Title of Information
Collection: Conditions of Participation for Critical Access Hospitals
(CAH) and Supporting Regulations; Use: The purpose of this package is
to request from the Office of Management and Budget (OMB) the approval
to reinstate, with changes, the information collection request,
associated with OMB Control Number 0938-1043, titled ``Critical Access
Hospital (CAH) Conditions of Participation (CoPs) and Supporting
Regulations.''
Sections 1820 and 1861(mm) of the Social Security Act provide that
CAHs participating Medicare meet certain specified requirements. The
regulations containing the information collection requirements are
located at 42 CFR part 485, subpart F. These regulations implement
sections 1102, 1138, 1814(a)(8), 1820(a-f), 1861(mm), 1864, and 1871 of
the Act.
This is a reinstatement of the information collection request that
expired on March 31, 2024. The previous iteration of this OMB No. 0938-
1043 (approved March 25, 2021) had a burden of 33,905 annual hours. For
this requested reinstatement, with changes, the estimated total annual
burden hours for the industry is 898,332 hours and the estimated annual
burden costs are $74,020,673.
The increase in burden hours from the prior package is primarily
due to new information collections associated with new CoPs for CAHs
outlined in the two CMS rules referenced below. The new CoPs include
multiple information collection requirements that are one-time burdens
for developing new policies and protocols and ongoing reporting
requirements, such as daily or biweekly reporting of respiratory
illnesses as well as maternal deaths. The reasons for the increased
information collections are discussed in more detail in the rules and
are summarized in the information collection request.
(1) Obstetrical services included in the proposed rule, Medicare
and Medicaid Programs: Hospital Outpatient Prospective Payment and
Ambulatory Surgical Center Payment Systems; Quality Reporting Programs,
Including
[[Page 83017]]
the Hospital Inpatient Quality Reporting Program; Health and Safety
Standards for Obstetrical Services in Hospitals and Critical Access
Hospitals; Prior Authorization; Requests for Information; Medicaid and
CHIP Continuous Eligibility; Medicaid Clinic Services Four Walls
Exceptions; Individuals Currently or Formerly in Custody of Penal
Authorities; Revision to Medicare Special Enrollment Period for
Formerly Incarcerated Individuals; and All-Inclusive Rate Add-On
Payment for High-Cost Drugs Provided by Indian Health Service and
Tribal Facilities, 89 FR 59186 (July 22, 2024) (hereinafter referred to
as the ``July 2024 Proposed Rule'').
(2) Reporting of acute respiratory illnesses in the interest of
public health and ensuring resiliency in the U.S. health care system
included in the Final rule: Medicare and Medicaid Programs and the
Children's Health Insurance Program; Hospital Inpatient Prospective
Payment Systems for Acute Care Hospitals and the Long-Term Care
Hospital Prospective Payment System and Policy Changes and Fiscal Year
2025 Rates; Quality Programs Requirements; and Other Policy Changes.
The aforementioned final rule, CMS-1808-F (RIN 0938-AV34), is currently
on display at the Office of the Federal Register and scheduled for
publication on August 28, 2024 (hereinafter referred to as the ``August
2024 Final Rule'').
The change in total burden hours is also due to prior information
collection requests are exempt from the PRA because the requirements
are customary and usual industry practice and would take place in the
absence of the Medicare and Medicaid programs. Form Number: CMS-10239
(OMB control number: 0938-1043); Frequency: Yearly; Affected Public:
Private Sector (Business or other for-profit); Number of Respondents:
1,245; Total Annual Responses: 9,145; Total Annual Hours: 898,332 (For
policy questions regarding this collection contact Claudia Molinar at
410-786-8445).
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-23737 Filed 10-11-24; 8:45 am]
BILLING CODE 4120-01-P
