[Federal Register Volume 86, Number 32 (Friday, February 19, 2021)]
[Notices]
[Pages 10282-10283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03419]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: 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 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 March 22, 2021.

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 website address at: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.

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; Title of Information Collection: Submissions 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 providers who provide 
such services in good faith can be reimbursed and exempted from 
sanctions.
    During emergencies, such as the current COVID-19 public health 
emergency (PHE), 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

[[Page 10283]]

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 Medicare-participating facilities and relocate 
patients/residents to other provider settings or across state lines, 
especially, during hurricane 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 PHE from providers and 
beneficiaries. CMS is not collecting information from these inquiries; 
we are merely responding to them.
    Prior to this request, CMS did not have a standard process or OMB 
approval for providers/suppliers impacted to submit 1135 waiver/
flexibility requests or inquiries, as these were generally seen on a 
smaller scale (natural disasters) prior to the COVID-19 public health 
emergency. CMS has provided general guidance to Medicare-participating 
facilities which can be viewed at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertEmergPrep/1135-Waivers. 
The requests and inquiries would be sent directly, via email, to the 
Survey Operations Group in each CMS Location (previously known as CMS 
Regional Offices) and the entity would provide a brief summary to CMS 
for a waiver/flexibility request or an answer to an inquiry. We are now 
developing a streamlined, automated process to standardize the 1135 
waiver requests and inquiries submitted based on lessons learned during 
COVID-19 PHE, primarily based on the volume of requests to ensure 
timely response to facility needs. The waiver request form was approved 
under an Emergency information collection request on October 15, 2020.
    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. This report includes demographic 
information about the provider, their operational status, beneficiary 
status, and planned resumption of normal operations. This information 
is provided whether or not a PHE has been declared. We are now 
developing a streamlined, automated process to standardize submission 
of this information directly by the provider during emergencies and 
eliminating the need for SA to provide it. It will consist of a public 
facing web form.
    This information will be used by CMS to receive, triage, respond to 
and report on requests and/or inquiries for Medicare, Medicaid, and 
CHIP beneficiaries. This information will be used to make decisions 
about approving or denying waiver and flexibility requests and may be 
used to identify trends that inform CMS Conditions for Coverage or 
Conditions for Participation policies during public health emergencies, 
when declared by the President and the HHS Secretary.
    Subsequent to the Emergency information collection request, we 
revised the package to include a second form, Healthcare Facility 
Status Workflow, which is for operational status information which will 
be used to assist providers in delivering critical care to 
beneficiaries during emergencies. Subsequent to the 60-day Federal 
Register notice which published on October 21, 2020 (85 FR 66990), we 
conducted user acceptance testing, resulting in enhancements to the 
public-facing web form that streamline the submission process and 
improve the flow and readability of the web form. These enhancements 
make the automated process easier to use for healthcare providers. We 
are also remediating a violation of the Paperwork Reduction Act by 
adding the Acute Hospital Care at Home waiver to this package. The 
initiative was established on November 23, 2020, in response to the 
unprecedented strain on hospital capacity due to the severe national 
increase in coronavirus disease 2019 (COVID-19). There is an increase 
in burden due to adding this waiver initiative to this package. 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: 5,729; Total Annual Responses: 
5,729; Total Annual Hours: 5,729. (For policy questions regarding this 
collection, contact Adriane Saunders at 404-562-7484.)

    Dated: February 16, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2021-03419 Filed 2-18-21; 8:45 am]
BILLING CODE 4120-01-P