[Federal Register Volume 87, Number 113 (Monday, June 13, 2022)]
[Notices]
[Pages 35784-35786]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 
http://www.regulations.gov. 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 https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.

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