[Federal Register Volume 89, Number 106 (Friday, May 31, 2024)]
[Notices]
[Pages 47153-47155]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11978]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10279 and CMS-10752]


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

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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 July 1, 2024.

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, please access 
the CMS PRA website by copying and pasting the following web address 
into your web browser: 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: Reinstatement with 
change to a previously approved collection; Title of Information 
Collection: Ambulatory Surgical Center Conditions for Coverage; Use: 
The purpose of this package is to request from the Office of Management 
and Budget (OMB) the approval to reinstate, with changes, the 
collection of information. The conditions for coverage for ASCs are 
regulation based on criteria described and codified at Sec.  42 CFR 
416. The conditions for coverage establish standards designed to ensure 
that each ASC has properly trained staff to provide the appropriate 
type and level of care for the environment of ASC patients.
    To determine ASC compliance with CMS standards, CMS, via the 
Secretary, authorizes States, through contracts, to survey ASC 
facilities. For Medicare purposes, certification is based on the State 
survey agency's recording of an ASC provider's compliance or non-
compliance with the health and safety conditions for coverage as 
published and codified in 42 CFR 416.40 to 485.54. The information 
collections aid surveyors as they assess ASC compliance or non-
compliance.
    The previous iteration of this information collection request had a 
burden of 262,946 annual hours at an annual cost of $28,144,370. For 
this requested reinstatement, with changes, the adjusted annual hourly 
burden is 97,527 hours at a cost of $11,089,427. The reasons for this 
change, is the previous iteration of this IC assumed the development 
associated with IC-1 and IC-2 occurred frequently. We have revised this 
as development of drafts only occur on a one-time basis. Form Number: 
CMS-10279 (OMB control number: 0938-1071); Frequency: Annual; Affected 
Public: Business or other for-profit and Not-for-profit institutions; 
Number of Respondents: 6,257; Total Annual Responses: 6,257; Total 
Annual Hours: 97,527. (For policy questions regarding this collection 
contact Claudia Molinar at 410-786-8445.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Submission of 
1135 Waiver Request Automated Process; Use: Waivers under Section 1135 
of the Social Security Act (the Act) and certain flexibilities allow 
the CMS to relax certain requirements, known as the Conditions of 
Participation (CoPs) or Conditions of Coverage to promote the health 
and safety of beneficiaries. Under Section 1135 of the Act, the 
Secretary may temporarily waive or modify certain Medicare, Medicaid, 
and Children's Health Insurance Program (CHIP) requirements to ensure 
that sufficient health care services are available to meet the needs of 
individuals enrolled in Social Security Act programs in the emergency 
area and time periods. These waivers ensure that healthcare entities/
caregivers who provide such services in good faith can be reimbursed 
and exempted from sanctions.
    During emergencies, CMS must be able to apply program waivers and 
flexibilities under section 1135 of the Social Security Act, in a 
timely manner to respond quickly to unfolding events. In a disaster or 
emergency, waivers and flexibilities assist health care providers/
suppliers in providing timely healthcare and services to people who 
have been affected and enables States, Federal districts, and U.S. 
territories to ensure Medicare and/or Medicaid beneficiaries have 
continued access to care. During disasters and emergencies, it is not 
uncommon to evacuate patients in health care facilities to other 
provider settings or across State lines, especially, during hurricane, 
wildfire, and tornado events. CMS must collect relevant information for 
which a provider is requesting a waiver or flexibility to make proper 
decisions about approving or denying such requests. Collection of this 
data aids in the prevention of gaps in access to care and services 
before, during, and after an emergency. CMS must also respond to 
inquiries related to a Public Health Emergency (PHE) from providers. 
CMS is not collecting information from these inquiries; we are merely 
responding to them.
    The collection of the information surrounding 1135 Waiver requests/
inquiries is based on a case-by-case basis and not regularly scheduled 
(e.g., quarterly, annually, by all providers/suppliers). The collection 
of information only occurs when the healthcare entity, impacted by an 
emergency, is requesting waivers/flexibilities under Section 1135 of 
the Act or inquiring about PHEs. The collection of information is also 
dependent on provider types; therefore, it is not a collection for all 
Medicare-participating facilities. In 2021, we implemented a 
streamlined, automated process to standardize the 1135 waiver requests 
and inquiries submitted based on lessons learned during the COVID-19 
PHE.

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    Furthermore, the normal operations of a healthcare provider are 
disrupted by emergencies or disasters occasionally. When this occurs, 
State Survey Agencies (SA) deliver a provider/beneficiary tracking 
report regarding the current status of all affected healthcare 
providers and their beneficiaries. We are revising this information 
collection streamlined automated process to update for clarity during 
emergencies. To quickly identify patient risks/needs, CMS added fields 
to assess sufficient staffing, equipment and supplies as well as added 
an assessment of a cyber security attack on the care and services 
provided to patients (if applicable). Moreover, to decrease the time/
effort of stakeholders (State Survey Agencies (SAs)/Providers) 
submitting this data during emergencies, CMS also added a feature to 
autofill multiple fields when the stakeholder documents a valid CMS 
Certification Number (CCN). This streamlined automated process will 
consist of a public facing web form as well as a process for SAs/
Providers to submit data using extracts (CSV or Excel) on emergent 
events impacting Health Care Facilities via automated mail handler 
system. Both processes (public facing web form and extracts via an 
automated mail handler system) are known as the Health Care Facility 
(HCF) Operational Status. Finally, Acute Hospital Care at Home waiver 
is granted at the individual hospital/CMS Certification Number (CCN) 
level and waives Sec.  482.23(b) and (b)(1) of the Hospital Conditions 
of Participation (CoPs) which require nursing services to be provided 
on premises 24 hours a day, 7 days a week and the immediate 
availability of a registered nurse for care of any patient (This waiver 
allows hospitals to utilize models of at-home hospital care). This 
Acute Hospital Care at Home web form was revised to add questions for 
the respondents to meet requirements for all hospitals for (1) the 
Patient Rights CoP at 42 CFR 482.13, (2) the Consolidated 
Appropriations Act of 2023 and (3) for emergency response. Form Number: 
CMS-10752 (OMB control number: 0938-1384); Frequency: Occasionally; 
Affected Public: Private Sector: Business or other for-profits and Not-
for-profit institutions and State, Local or Tribal Governments; Number 
of Respondents: 1,020; Total Annual Responses: 11,916; Total Annual 
Hours: 11,916. (For policy questions regarding this collection, contact 
Adriane Saunders at 404-562-7484.)

William N. Parham III,
Director, Division of Information Collections and Regulatory Impacts, 
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-11978 Filed 5-30-24; 8:45 am]
BILLING CODE 4120-01-P