[Federal Register Volume 81, Number 122 (Friday, June 24, 2016)]
[Notices]
[Pages 41307-41308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15029]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10455 and CMS-R-290]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid 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 any of the following subjects: (1) 
The necessity and utility of the proposed information collection for 
the proper performance of the agency's functions; (2) the accuracy of 
the estimated burden; (3) ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) the use of 
automated collection techniques or other forms of information 
technology to minimize the information collection burden.

DATES: Comments must be received by August 23, 2016.

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' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786-
1326.

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-10455 Report of a Hospital Death Associated With Restraint or 
Seclusion

CMS-R-290 Medicare Program: Procedures for Making National Coverage 
Decisions

    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

[[Page 41308]]

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: Report of a 
Hospital Death Associated with Restraint or Seclusion; Use: Executive 
Order 13563, Improving Regulation and Regulatory Review, was signed on 
January 18, 2011. The order recognized the importance of a streamlined, 
effective, and efficient regulatory framework designed to promote 
economic growth, innovation, job creation, and competitiveness. Each 
agency was directed to establish an ongoing plan to reduce or eliminate 
burdensome, obsolete, or unnecessary regulations to create a more 
efficient and flexible structure.
    The regulation that was published on May, 16, 2012 (77 FR 29034) 
included a reduction in the reporting requirement related to hospital 
deaths associated with the use of restraint or seclusion, Sec.  
482.13(g). Hospitals are no longer required to report to CMS those 
deaths where there was no use of seclusion and the only restraint was 
2-point soft wrist restraints. It is estimated that this will reduce 
the volume of reports that must be submitted by 90 percent for 
hospitals. In addition, the final rule replaced the previous 
requirement for reporting via telephone to CMS, which proved to be 
cumbersome for both CMS and hospitals, with a requirement that allows 
submission of reports via telephone, facsimile or electronically, as 
determined by CMS. Finally, the amount of information that CMS needs 
for each death report in order for CMS to determine whether further on-
site investigation is needed has been reduced.
    The Child Health Act (CHA) of 2000 established in title V, part H, 
section 591 of the Public Health Service Act (PHSA) minimum 
requirements concerning the use of restraints and seclusion in 
facilities that receive support with funds appropriated to any Federal 
department or agency. In addition, the CHA enacted section 592 of the 
PHSA, which establishes minimum mandatory reporting requirements for 
deaths in such facilities associated with use of restraint or 
seclusion. Provisions implementing this statutory reporting requirement 
for hospitals participating in Medicare are found at 42 CFR 482.13(g), 
as revised in the final rule that published on May 16, 2012 (77 FR 
29034). Form Number: CMS-10455 (OMB Control Number: 0938-1210); 
Frequency: Occasionally; Affected Public: Private Sector; Number of 
Respondents: 4,900. Number of Responses: 24,500. Total Annual Hours: 
8,085. (For policy questions regarding this collection contact Karina 
Meushaw at 410-786-1000.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title: Medicare Program: Procedures for Making 
National Coverage Decisions; Use: We revised our April 27, 1999 (64 FR 
22619) notice and published a new notice on September 26, 2003 (68 FR 
55634) that described the process we use to make Medicare coverage 
decisions including decisions regarding whether new technology and 
services can be covered. We have made changes to our internal 
procedures in response to the comments we received following 
publication of the 1999 notice and experience under our new process. 
Over the past several years, we received numerous suggestions to 
further revise our process to continue to make it more open, 
responsive, and understandable to the public. We share the goal of 
increasing public participation in the development of Medicare coverage 
issues. This will assist us in obtaining the information we require to 
make a national coverage determination in a timely manner and ensuring 
that the Medicare program continues to meet the needs of its 
beneficiaries. Form Number: CMS-R-290 (OMB control number: 0938-0776); 
Frequency: Annual; Affected Public: Private Sector: Business or other 
for-profits; Number of Respondents: 200; Total Annual Responses: 200; 
Total Annual Hours: 8,000. (For policy questions regarding this 
collection contact Katherine Tillman at 410-786-9252.)

    Dated: June 21, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2016-15029 Filed 6-23-16; 8:45 am]
 BILLING CODE 4120-01-P