[Federal Register Volume 86, Number 159 (Friday, August 20, 2021)]
[Notices]
[Pages 46854-46855]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17908]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10280, CMS-1557 and CMS-3070G-I]


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 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 October 19, 2021.

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.html.

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-10280 Home Health Change of Care Notice
CMS-1557 Survey Report Form for Clinical Laboratory Improvement 
Amendments (CLIA) and Supporting Regulations
CMS-3070G-I ICF/IID Survey Report Form and Supporting Regulations

    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: Extension of a currently 
approved collection; Title of the Information Collection: Home Health 
Change of Care Notice; Use: The purpose of the Home Health Change of 
Care Notice (HHCCN) is to notify original Medicare beneficiaries 
receiving home health care benefits of plan of care changes. Home 
health agencies (HHAs) are required to provide written notice to 
Original Medicare beneficiaries under various circumstances involving 
the reduction or termination of items and/or services consistent with 
Home Health Agencies Conditions of Participation (COPs).
    The home health COP requirements are set forth in Sec.  1891[42 
U.S.C. 1395bbb] of the Social Security Act (the Act). The implementing 
regulations under 42 CFR 484.10(c) specify that Medicare patients 
receiving HHA services have rights. The patient has the right to be 
informed, in advance about the care to be furnished, and of any changes 
in the care to be furnished. The HHA must advise the patient in advance 
of the disciplines that will furnish care, and the frequency of visits 
proposed to be furnished. The HHA must advise the patient in advance of 
any change in the plan of care before the change is made.''
    Notification is required for covered and non-covered services 
listed in the plan of care (POC). The beneficiary will use the 
information provided to decide whether or not to pursue alternative 
options to continue receiving the care noted on the HHCCN. Form Number: 
CMS-10280 (OMB control number: 0938-1196); Frequency: Yearly; Affected 
Public: Private Sector (Business or other for-profits, Not-for-Profit 
Institutions); Number of Respondents: 11,157; Total Annual Responses: 
12,385,108; Total Annual Hours: 824,848. (For policy questions 
regarding this collection contact Jennifer McCormick at 410-786-2852.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Survey Report 
Form for Clinical Laboratory Improvement Amendments (CLIA) and 
Supporting Regulations; Use: The form is used to report surveyor 
findings during a CLIA survey. For each type of survey conducted (i.e., 
initial certification, recertification, validation, complaint, 
addition/deletion of specialty/subspecialty, transfusion fatality 
investigation, or revisit inspections) the Survey Report Form 
incorporates the requirements specified in the CLIA regulations. Form 
Number: CMS-1557 (OMB control number: 0938-0544); Frequency: 
Biennially; Affected Public: Private sector (Business or other for-
profit and Not-for-profit institutions, State, Local or Tribal 
Governments and Federal Government); Number of Respondents: 15,975; 
Total

[[Page 46855]]

Annual Responses: 7,988; Total Annual Hours: 3,994. (For policy 
questions regarding this collection contact Kathleen Todd at 410-786-
3385).
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: ICF/IID Survey 
Report Form and Supporting Regulations; Use: The information collected 
with forms 3070G, CMS-3070H and CMS-3070I is used by the surveyors from 
the State Survey Agencies (SAs) to determine the level of compliance 
with the ICF/IID Conditions of Participation (CoPs) necessary to 
participate in the Medicare/Medicaid program and to report any non-
compliance with the ICF/IID CoPs to the Federal government. These forms 
summarize the survey team characteristics, facility characteristics, 
client population, and the special needs of clients. These forms are 
used in conjunction with the CMS regulation text and additional 
surveyor aids such as the CMS interpretive guidelines and probes. The 
CMS-3070G-I forms serves as coding worksheets, designed to facilitate 
data entry and retrieval into the Automated Survey Processing 
Environment Suite (ASPEN) in the State and at the CMS regional offices. 
Form Number: CMS-3070G-I (OMB control number: 0938-0062); Frequency: 
Reporting--Yearly; Affected Public: Business or other for-profits and 
Not-for-profit institutions; Number of Respondents: 5,758; Total Annual 
Responses: 5,758; Total Annual Hours: 17,274. (For policy questions 
regarding this collection contact Caroline Gallaher at 410-786-8705.)

    Dated: August 17, 2021.
William N. Parham, III
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2021-17908 Filed 8-19-21; 8:45 am]
BILLING CODE 4120-01-P