[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.

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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 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