Notice2024-11978
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 31, 2024
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 89 Issue 106 (Friday, May 31, 2024)</title>
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[Federal Register Volume 89, Number 106 (Friday, May 31, 2024)]
[Notices]
[Pages 47153-47155]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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, please access
the CMS PRA website by copying and pasting the following web address
into your web browser: <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: 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
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</html>Indexed from Federal Register on May 31, 2024.
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