Agency Information Collection Activities: Submission for OMB Review; Comment Request, 51985-51987 [2022-18243]
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Federal Register / Vol. 87, No. 163 / Wednesday, August 24, 2022 / Notices
Improvement Organization (QIO) and
how to file a request. For all Medicare
beneficiaries, hospitals must deliver
valid, written notice of a beneficiary’s
rights as a hospital inpatient, including
discharge appeal rights. The hospital
must use a standardized notice, as
specified by CMS. This is satisfied by
IM delivery.
Consistent with 42 CFR 405.1205 for
Original Medicare and 422.620 for
Medicare health plans, hospitals must
provide the initial IM within 2 calendar
days of admission. A follow-up copy of
the signed IM is given no more than 2
calendar days before discharge. The
follow-up copy is not required if the
first IM is provided within 2 calendar
days of discharge. In accordance with 42
CFR 405.1206 for Original Medicare and
422.622 for Medicare health plans, if a
beneficiary/enrollee appeals the
discharge decision, the beneficiary/
enrollee and the QIO must receive a
detailed explanation of the reasons
services should end. This detailed
explanation is provided to the
beneficiary/enrollee using the DND, the
second notice included in this renewal
package. Form Number: CMS–10065/
10066 (OMB control number: 0938–
1019); Frequency: Yearly; Affected
Public: Private Sector (Business or other
for-profits, Not-for-Profit Institutions);
Number of Respondents: 14,087,086;
Total Annual Responses: 14,087,086;
Total Annual Hours: 2,385,107. (For
policy questions regarding this
collection contact Janet Miller at
Janet.Miller@cms.hhs.gov).
2. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Medicare
Outpatient Observation Notice (MOON);
Use: The Medicare Outpatient
Observation Notice (MOON) serves as
the written notice component of this
mandatory notification process. The
standardized content of the MOON
includes all informational elements
required by statute, in language
understandable to beneficiaries, and
fulfils the regulatory requirements at 42
CFR part 489.20(y).
The MOON is a standardized notice
delivered to persons entitled to
Medicare benefits under Title XVIII of
the Act who receive more than 24 hours
of observation services, informing them
that their hospital stay is outpatient and
not inpatient, and the implications of
being an outpatient. This information
collection applies to beneficiaries in
Original Medicare and enrollees in
Medicare health plans. Form Number:
CMS–10611 (OMB control number:
0938–1308); Frequency: Yearly; Affected
Public: State, Local, or Tribal
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Governments; Number of Respondents:
4,312; Total Annual Responses:
683,222; Total Annual Hours: 170,806.
(For policy questions regarding this
collection contact Janet Miller at
Janet.Miller@cms.hhs.gov/).
Dated: August 18, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2022–18195 Filed 8–23–22; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10668, CMS–
10455 and CMS–10430]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
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.
DATES: Comments on the collection(s) of
information must be received by the
OMB desk officer by September 23,
2022.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
SUMMARY:
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51985
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, you may make your request
using one of following:
1. Access CMS’ website address at:
https://www.cms.gov/Regulationsand-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.
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: Revision of a currently
approved collection; Quality Measures
and Administrative Procedures for the
Hospital-Acquired Condition Reduction
Program; Use: The Centers for Medicare
& Medicaid Services (CMS) is
committed to promoting higher quality
healthcare and improving outcomes for
Medicare beneficiaries. The HospitalAcquired Condition (HAC) Reduction
Program is established by section
1886(p) of the Social Security Act, as
added by Section 3008 of the Affordable
Care Act (Pub. L. 111–148), and requires
the Secretary to reduce payments to
subsection (d) hospitals in the worstperforming quartile of all subsection (d)
hospitals by 1 percent effective
beginning on October 1, 2014 and
subsequent years. For the FY 2025
program year we are proposing in the
Fiscal Year (FY) 2023 Inpatient
Prospective Payment System (IPPS)/
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Federal Register / Vol. 87, No. 163 / Wednesday, August 24, 2022 / Notices
Long-Term Care Hospital (LTCH) PPS
proposed rule to suppress all six
measures in the HAC Reduction
Program and not calculate measure
scores or Total HAC Scores for any
hospital such that no hospital will
receive a payment reduction due to the
significant impacts of the COVID–19
pandemic on the quality measures. We
are not proposing any policies in the FY
2023 IPPS/LTCH PPS proposed rule
which result in a change to our
estimated burden. To administer its
requirements, the HAC Reduction
Program relies on data collection
established through the Centers for
Disease Control and Prevention’s (CDC)
OMB control number, 0920–0666, and
validation processes established through
the Hospital Inpatient Quality Reporting
(IQR) Program’s OMB control number,
0938–1022. However, in the FY 2019
IPPS/LTCH PPS final rule, the Hospital
IQR Program finalized the removal of
the CDC National Healthcare Safety
Network (NHSN) Healthcare-associated
Infection (HAI) measures and NHSN
HAI validation processes beginning on
January 1, 2020. To continue validation
of these measures, the HAC Reduction
Program adopted validation templates
similar to the ones previously used
under the Hospital IQR Program. These
templates continue the HAC Reduction
Program’s use and validation of NHSN
HAI data.
The HAC Reduction Program
identifies the worst-performing quartile
of hospitals by calculating a Total HAC
Score derived from the CMS Patient
Safety and Adverse Events Composite
(CMS PSI 90) and NHSN HAI measures,
which require that we collect claimsbased and chart-abstracted measures
data, respectively. The HAC Reduction
Program validates NHSN HAI data
reported by subsection (d) hospitals to
ensure that hospitals report correct
NHSH HAI measure data, and the Total
HAC Score is calculated using accurate
data. The HAC Reduction Program may
penalize any hospitals that fail
validation by assigning the maximum
Winsorized z-score for the set of
measures that fail validation, for use in
the Total HAC Score calculation. The
collection of information for validation
is necessary to ensure that the HAC
Reduction Program and Total HAC
Score are administered fairly.
The HAC Reduction Program will
continue to receive NHSN HAI data for
hospitals from CDC. Because the burden
associated with submitting data for the
HAI measures (CDI, CAUTI, CLABSI,
MRSA, and SSI) is captured under a
separate OMB control number, 0920–
0666, we do not provide an independent
estimate of the burden associated with
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collecting data for these measures for
the HAC Reduction Program. We also do
not provide an estimate of burden for
the claims-based PSI 90 measure,
because this measure is collected using
Medicare FFS claims that hospitals are
already submitting to the Medicare
program for payment purposes. We also
do not provide an estimate of burden for
validation of data submitted for the PSI
90 measure, because Medicare claims
are audited under the Medicare Fee for
Service (FFS) Recovery Audit Program.
Form Number: CMS–10668 (OMB
control number: 0938–1352); Frequency:
Yearly; Affected Public: Private Sector
(Business or other for-profit and Not-forprofit institutions), Federal Government,
and State, Local or Tribal Governments;
Number of Respondents: 400; Total
Annual Responses: 400; Total Annual
Hours: 28,800. (For policy questions
regarding this collection contact Jennifer
Tate at 410–786–0428).
2. Type of Information Collection
Request: Reinstatement with change of a
previously approved collection; Title of
Information Collection: Report of a
Hospital Death Associated with
Restraint or Seclusion; Use: Provisions
implementing this statutory reporting
requirement for hospitals participating
in Medicare are found at 42 CFR
482.13(g), as revised in the final rule
that published on May 16, 2012 (77 FR
29034). This regulation also applies to
Critical Access Hospitals (CAHs) with
distinct part units (DPUs); since CAH
DPUs are subject to the Hospital
Conditions of Participation. The
regulation at 42 CFR 482.13(g) requires
that hospitals and CAHs with DPUs
report deaths associated with the use of
restraint and/or seclusion directly to the
CMS locations. This regulation requires
that information about patient deaths
associated with the use of restraint and/
or seclusion must be reported to the
CMS Locations using the online CMS–
10455 form titled ‘‘Report Of A Hospital
Death Associated With The Use Of
Restraint Or Seclusion.’’
When a death occurs in a hospital
(including Critical Access Hospital
(CAH) with a rehabilitation or
psychiatric Distinct Part Unit (DPU))
that is associated with the use of
restraints and/or seclusion, the hospital
staff must complete the online Form
CMS–10455 (42 CFR 482.13(g)(1)). The
hospital staff must also document the
date and time that CMS was notified of
the death in the patient’s medical record
(42 CFR 482.13(g)(3)(i)).
When a death occurs during the use
of 2-point soft cloth wrist restraints with
no seclusion, or within 24 hours after
the patient was removed from such
restraints, the hospital must document
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the information required by 42 CFR
482.13(g)(4)(ii) into a hospital log or
internal system within 7 days from the
date of death (42 CFR 482.13(g)(4)(i)).
The hospital is not required to submit
this log or internal records to the CMS
Location, however, they must be made
available in either written or electronic
form to CMS immediately upon request
(42 CFR 482.13(g)(4)(iii)). In addition,
the hospital staff must also document
the date and time that the required
information was entered into the
hospital’s log or internal system in the
patient’s medical record (42 CFR
482.13(g)(3)(ii)). Form Number: CMS–
10455 (OMB control number: 0938–
1210); Frequency: Occasionally;
Affected Public: Private Sector; Number
of Respondents: 3,137; Number of
Responses: 3,137; Total Annual Hours:
1,210. (For policy questions regarding
this collection contact Caroline Gallaher
at 410–786–8705.)
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Information
Collection Requirements for Compliance
with Individual and Group Market
Reforms under Title XXVII of the Public
Health Service Act; Use: Sections 2723
and 2761 of the Public Health Service
Act (PHS Act) direct the Centers for
Medicare and Medicaid Services (CMS)
to enforce a provision (or provisions) of
title XXVII of the PHS Act (including
the implementing regulations in parts
144, 146, 147, and 148 of title 45 of the
Code of Federal Regulations) with
respect to health insurance issuers when
a state has notified CMS that it has not
enacted legislation to enforce or that it
is not otherwise enforcing a provision
(or provisions) of the group and
individual market reforms with respect
to health insurance issuers, or when
CMS has determined that a state is not
substantially enforcing one or more of
those provisions. Section 2723 of the
PHS Act directs CMS to enforce an
applicable provision (or applicable
provisions) of title XXVII of the PHS Act
(including the implementing regulations
in parts 146 and 147 of title 45 of the
Code of Federal Regulations) with
respect to group health plans that are
non-Federal governmental plans. This
collection of information includes
requirements that are necessary for CMS
to conduct compliance review activities.
Form Number: CMS–10430 (OMB
control number: 0938–0702); Frequency:
Annually; Affected Public: Private
Sector, State, Local, or Tribal
Governments; Number of Respondents:
794; Total Annual Responses: 51,385;
Total Annual Hours: 1,786. (For policy
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Federal Register / Vol. 87, No. 163 / Wednesday, August 24, 2022 / Notices
questions regarding this collection
contact Usree Bandyopadhyay at 410–
786–6650).
Dated: August 19, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2022–18243 Filed 8–23–22; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10379]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
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 (the
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
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates 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 must be received by
October 24, 2022.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
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SUMMARY:
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to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number:ll, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
website address at https://
www.cms.gov/Regulations-andGuidance/Legislation/
PaperworkReductionActof1995/PRAListing
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10379—Rate Increase Disclosure
and Review Reporting Requirements
Under the 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
requires federal agencies to publish a
60-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.
Information Collection
1. Type of Information Collection
Request: Revision of a previously
approved information collection; Title
of Information Collection: Rate Increase
Disclosure and Review Reporting
Requirements; Use: 45 CFR part 154
implements the annual review of
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51987
unreasonable increases in premiums for
health insurance coverage called for by
section 2794. The regulation established
a rate review program to ensure that all
rate increases that meet or exceed an
established threshold are reviewed by a
state or the Centers for Medicare and
Medicaid Services (CMS) to determine
whether the rate increases are
unreasonable. Accordingly, issuers
offering non-grandfathered health
insurance coverage in the individual
and/or small group markets are required
to submit Rate Filing Justifications to
CMS. Section 154.103 exempts
grandfathered health plan coverage as
defined in 45 CFR 147.140, excepted
benefits as described in section 2791(c)
of the PHS Act and student health
insurance coverage, as defined in
§ 147.145, from Federal rate review
requirements.
The Rate Filing Justification consists
of three parts. All issuers must continue
to submit a Uniform Rate Review
Template (URRT) (Part I of the Rate
Filing Justification) for all single risk
pool plans. Section 154.200(a)(1)
establishes a 15 percent federal default
threshold for reasonableness review.
Issuers that submit a rate filing that
includes a plan that meets or exceeds
the threshold must include a written
description justifying the rate increase,
also known as the consumer
justification narrative (Part II of the Rate
Filing Justification). We note that the
threshold set by CMS constitutes a
minimum standard and most states
currently employ stricter rate review
standards and may continue to do so.
Issuers offering a QHP or any single risk
pool submission containing a rate
increase of any size must continue to
submit an actuarial memorandum (Part
III of the Rate Filing Justification). Form
Number: CMS–10379 (OMB control
number: 0938–1141); Frequency:
Annually; Affected Public: Private
Sector; Businesses or other for-profits,
Not-for-profit institutions; Number of
Respondents: 626; Total Annual
Responses: 820; Total Annual Hours:
17,788. (For policy questions regarding
this collection contact Lisa Cuozzo at
410–786–1746.)
Dated: August 19, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2022–18244 Filed 8–23–22; 8:45 am]
BILLING CODE 4120–01–P
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]]>Agencies
[Federal Register Volume 87, Number 163 (Wednesday, August 24, 2022)]
[Notices]
[Pages 51985-51987]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18243]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10668, CMS-10455 and CMS-10430]
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 September 23, 2022.
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, you may make
your request using one of following:
1. Access CMS' website address at: 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: Revision of a currently
approved collection; Quality Measures and Administrative Procedures for
the Hospital-Acquired Condition Reduction Program; Use: The Centers for
Medicare & Medicaid Services (CMS) is committed to promoting higher
quality healthcare and improving outcomes for Medicare beneficiaries.
The Hospital-Acquired Condition (HAC) Reduction Program is established
by section 1886(p) of the Social Security Act, as added by Section 3008
of the Affordable Care Act (Pub. L. 111-148), and requires the
Secretary to reduce payments to subsection (d) hospitals in the worst-
performing quartile of all subsection (d) hospitals by 1 percent
effective beginning on October 1, 2014 and subsequent years. For the FY
2025 program year we are proposing in the Fiscal Year (FY) 2023
Inpatient Prospective Payment System (IPPS)/
[[Page 51986]]
Long-Term Care Hospital (LTCH) PPS proposed rule to suppress all six
measures in the HAC Reduction Program and not calculate measure scores
or Total HAC Scores for any hospital such that no hospital will receive
a payment reduction due to the significant impacts of the COVID-19
pandemic on the quality measures. We are not proposing any policies in
the FY 2023 IPPS/LTCH PPS proposed rule which result in a change to our
estimated burden. To administer its requirements, the HAC Reduction
Program relies on data collection established through the Centers for
Disease Control and Prevention's (CDC) OMB control number, 0920-0666,
and validation processes established through the Hospital Inpatient
Quality Reporting (IQR) Program's OMB control number, 0938-1022.
However, in the FY 2019 IPPS/LTCH PPS final rule, the Hospital IQR
Program finalized the removal of the CDC National Healthcare Safety
Network (NHSN) Healthcare-associated Infection (HAI) measures and NHSN
HAI validation processes beginning on January 1, 2020. To continue
validation of these measures, the HAC Reduction Program adopted
validation templates similar to the ones previously used under the
Hospital IQR Program. These templates continue the HAC Reduction
Program's use and validation of NHSN HAI data.
The HAC Reduction Program identifies the worst-performing quartile
of hospitals by calculating a Total HAC Score derived from the CMS
Patient Safety and Adverse Events Composite (CMS PSI 90) and NHSN HAI
measures, which require that we collect claims-based and chart-
abstracted measures data, respectively. The HAC Reduction Program
validates NHSN HAI data reported by subsection (d) hospitals to ensure
that hospitals report correct NHSH HAI measure data, and the Total HAC
Score is calculated using accurate data. The HAC Reduction Program may
penalize any hospitals that fail validation by assigning the maximum
Winsorized z-score for the set of measures that fail validation, for
use in the Total HAC Score calculation. The collection of information
for validation is necessary to ensure that the HAC Reduction Program
and Total HAC Score are administered fairly.
The HAC Reduction Program will continue to receive NHSN HAI data
for hospitals from CDC. Because the burden associated with submitting
data for the HAI measures (CDI, CAUTI, CLABSI, MRSA, and SSI) is
captured under a separate OMB control number, 0920-0666, we do not
provide an independent estimate of the burden associated with
collecting data for these measures for the HAC Reduction Program. We
also do not provide an estimate of burden for the claims-based PSI 90
measure, because this measure is collected using Medicare FFS claims
that hospitals are already submitting to the Medicare program for
payment purposes. We also do not provide an estimate of burden for
validation of data submitted for the PSI 90 measure, because Medicare
claims are audited under the Medicare Fee for Service (FFS) Recovery
Audit Program. Form Number: CMS-10668 (OMB control number: 0938-1352);
Frequency: Yearly; Affected Public: Private Sector (Business or other
for-profit and Not-for-profit institutions), Federal Government, and
State, Local or Tribal Governments; Number of Respondents: 400; Total
Annual Responses: 400; Total Annual Hours: 28,800. (For policy
questions regarding this collection contact Jennifer Tate at 410-786-
0428).
2. Type of Information Collection Request: Reinstatement with
change of a previously approved collection; Title of Information
Collection: Report of a Hospital Death Associated with Restraint or
Seclusion; Use: Provisions implementing this statutory reporting
requirement for hospitals participating in Medicare are found at 42 CFR
482.13(g), as revised in the final rule that published on May 16, 2012
(77 FR 29034). This regulation also applies to Critical Access
Hospitals (CAHs) with distinct part units (DPUs); since CAH DPUs are
subject to the Hospital Conditions of Participation. The regulation at
42 CFR 482.13(g) requires that hospitals and CAHs with DPUs report
deaths associated with the use of restraint and/or seclusion directly
to the CMS locations. This regulation requires that information about
patient deaths associated with the use of restraint and/or seclusion
must be reported to the CMS Locations using the online CMS-10455 form
titled ``Report Of A Hospital Death Associated With The Use Of
Restraint Or Seclusion.''
When a death occurs in a hospital (including Critical Access
Hospital (CAH) with a rehabilitation or psychiatric Distinct Part Unit
(DPU)) that is associated with the use of restraints and/or seclusion,
the hospital staff must complete the online Form CMS-10455 (42 CFR
482.13(g)(1)). The hospital staff must also document the date and time
that CMS was notified of the death in the patient's medical record (42
CFR 482.13(g)(3)(i)).
When a death occurs during the use of 2-point soft cloth wrist
restraints with no seclusion, or within 24 hours after the patient was
removed from such restraints, the hospital must document the
information required by 42 CFR 482.13(g)(4)(ii) into a hospital log or
internal system within 7 days from the date of death (42 CFR
482.13(g)(4)(i)). The hospital is not required to submit this log or
internal records to the CMS Location, however, they must be made
available in either written or electronic form to CMS immediately upon
request (42 CFR 482.13(g)(4)(iii)). In addition, the hospital staff
must also document the date and time that the required information was
entered into the hospital's log or internal system in the patient's
medical record (42 CFR 482.13(g)(3)(ii)). Form Number: CMS-10455 (OMB
control number: 0938-1210); Frequency: Occasionally; Affected Public:
Private Sector; Number of Respondents: 3,137; Number of Responses:
3,137; Total Annual Hours: 1,210. (For policy questions regarding this
collection contact Caroline Gallaher at 410-786-8705.)
3. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Information
Collection Requirements for Compliance with Individual and Group Market
Reforms under Title XXVII of the Public Health Service Act; Use:
Sections 2723 and 2761 of the Public Health Service Act (PHS Act)
direct the Centers for Medicare and Medicaid Services (CMS) to enforce
a provision (or provisions) of title XXVII of the PHS Act (including
the implementing regulations in parts 144, 146, 147, and 148 of title
45 of the Code of Federal Regulations) with respect to health insurance
issuers when a state has notified CMS that it has not enacted
legislation to enforce or that it is not otherwise enforcing a
provision (or provisions) of the group and individual market reforms
with respect to health insurance issuers, or when CMS has determined
that a state is not substantially enforcing one or more of those
provisions. Section 2723 of the PHS Act directs CMS to enforce an
applicable provision (or applicable provisions) of title XXVII of the
PHS Act (including the implementing regulations in parts 146 and 147 of
title 45 of the Code of Federal Regulations) with respect to group
health plans that are non-Federal governmental plans. This collection
of information includes requirements that are necessary for CMS to
conduct compliance review activities. Form Number: CMS-10430 (OMB
control number: 0938-0702); Frequency: Annually; Affected Public:
Private Sector, State, Local, or Tribal Governments; Number of
Respondents: 794; Total Annual Responses: 51,385; Total Annual Hours:
1,786. (For policy
[[Page 51987]]
questions regarding this collection contact Usree Bandyopadhyay at 410-
786-6650).
Dated: August 19, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2022-18243 Filed 8-23-22; 8:45 am]
BILLING CODE 4120-01-P
