Notice2022-18243
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Primary source
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Published
August 24, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 163 (Wednesday, August 24, 2022)</title>
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[Federal Register Volume 87, Number 163 (Wednesday, August 24, 2022)]
[Notices]
[Pages 51985-51987]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.
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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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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: <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing</a>.
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
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</html>Indexed from Federal Register on August 24, 2022.
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