[Federal Register Volume 86, Number 148 (Thursday, August 5, 2021)]
[Notices]
[Pages 42841-42843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16755]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10148 and CMS-10784]


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

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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 4, 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-10148 HIPAA Administrative Simplification (Non-Privacy/Security) 
Complaint Form
CMS-10784 The Home Health Care CAHPS[supreg] Survey (HHCAHPS) Mode 
Experiment

    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 Information Collection: HIPAA 
Administrative Simplification (Non-Privacy/Security) Complaint Form; 
Use: The Secretary of Health and Human Services (HHS), hereafter known 
as ``The Secretary,'' codified 45 CFR parts 160 and 164 Administrative 
Simplification provisions that apply to the enforcement of the Health 
Insurance Portability and Accountability Act of 1996 Public Law 104-191 
(HIPAA). The provisions address rules relating to the investigation of 
non-compliance of the HIPAA Administrative Simplification code sets, 
unique identifiers, operating rules, and transactions. 45 CFR 160.306, 
Complaints to the Secretary, provides for investigations of covered 
entities by the Secretary. Further, it outlines the procedures and 
requirements for filing a complaint against a covered entity.
    Anyone can file a complaint if he or she suspects a potential 
violation. Persons believing that a covered entity is not utilizing the 
adopted Administrative Simplification provisions of HIPAA are 
voluntarily requested to file a complaint with CMS via the 
Administrative Simplification Enforcement and Testing Tool (ASETT) 
online system, by mail, or by sending an email to the HIPAA mailbox at 
[email protected]. Information provided on the standard form 
will be used during the investigation process to validate non-
compliance of HIPAA Administrative Simplification provisions.
    This standard form collects identifying and contact information of 
the complainant, as well as the identifying and contact information of 
the filed against entity (FAE). This information enables CMS to respond 
to the complainant and gather more information if necessary, and to 
contact the FAE to discuss the complaint and CMS' findings. Form 
Number: CMS-10148 (OMB control number: 0938-0948); Frequency: 
Occasionally; Affected Public: Private sector, Business or Not-for-
profit institutions, State, Local, or Tribal Governments, Federal 
Government, Not-for-profits institutions; Number of Respondents: 21; 
Total Annual Responses: 21; Total Annual Hours: 12. (For policy 
questions regarding this collection contact Kevin Stewart at 410-786-
6149).
    2. Type of Information Collection Request: New collection (Request 
for a new OMB control); Title of Information Collection: The Home 
Health Care CAHPS[supreg] Survey (HHCAHPS) Mode Experiment; Use: The 
reporting of quality data by HHAs is mandated by Section 
1895(b)(3)(B)(v)(II) of the Social Security Act (``the Act''). This 
statute requires that ``each home health agency shall submit to the 
Secretary such data that the Secretary determines are appropriate for 
the measurement of health care quality. Such data shall be submitted in 
a form and manner, and at a time, specified by the Secretary for 
purposes of this clause.'' HHCAHPS data are mandated in the Medicare 
regulations at 42 CFR 484.250(a), which requires HHAs to submit HHCAHPS 
data to meet the quality reporting requirements of section 
1895(b)(3)(B)(v) of the Act. This collection of information is 
necessary to be able to test updates to the HHCAHPS survey and 
administration protocols.
    CMS proposes to conduct a mode experiment with the main goal of 
testing the effects of a web-based mode on response rates and scores as 
an addition to the three currently approved modes (OMB Control Number: 
0938-1370). The addition of a web mode will give HHAs an alternative or 
an addition to the use of mail and telephone modes. CMS is also 
interested in testing a revised, shorter version of the HHCAHPS survey, 
based on feedback from patients and stakeholders.
    The data collected from the HHCAHPS Survey mode experiment will be 
used for the following purposes:
     Test the shortened survey instrument, including several 
new items;
     Compare survey responses across the four proposed modes to 
determine if adjustments are needed to ensure that data collection mode 
does not influence results; and
     Determine if and by how much patient characteristics 
affect the patients' rating of the care they receive

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and adjust results based on those factors.
    The mode experiment is designed to examine the effects of the 
shortened survey on response rates and scores and to provide precise 
adjustment estimates for survey items and composites on the shortened 
survey instrument. Information from this mode experiment will help CMS 
determine whether an additional mode of administration (i.e., Web data 
collection) should be included and a shortened survey instrument should 
be used in the current national implementation of the HHCAHPS Survey. 
Form Number: CMS-10784 (OMB control number: 0938-New); Frequency: 
Annually; Affected Public: Individuals or Households; Number of 
Respondents: 6,280; Total Annual Responses: 6,280; Total Annual Hours: 
1,049. (For policy questions regarding this collection contact Lori E. 
Teichman at 410-786-6684).

    Dated: August 2, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2021-16755 Filed 8-4-21; 8:45 am]
BILLING CODE 4120-01-P