Notice2022-12721
Agency Information Collection Activities: Proposed Collection; Comment Request
Primary source
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Published
June 13, 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 (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.
Full Text
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<title>Federal Register, Volume 87 Issue 113 (Monday, June 13, 2022)</title>
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[Federal Register Volume 87, Number 113 (Monday, June 13, 2022)]
[Notices]
[Pages 35784-35786]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-12721]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10668 and CMS-10455]
Agency Information Collection Activities: Proposed Collection;
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 (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
[[Page 35785]]
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 August 12, 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
<a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' 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: __, 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 <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 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-10668 Applications for Part C Medicare Advantage, 1876 Cost Plans,
and Employer Group Waiver Plans to Provide Part C Benefits
CMS-10455 Report of a Hospital Death Associated with Restraint or
Seclusion
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 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)/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
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regarding this collection contact Jennifer Tate at 410-786-0428).
2. Type of Information Collection Request: Revision of a currently
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.)
Dated: June 8, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2022-12721 Filed 6-10-22; 8:45 am]
BILLING CODE 4120-01-P
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