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###### Department of Health and Human Services

###### Centers for Medicare & Medicaid Services

          - [Document Identifier: CMS-10549 and CMS-10455]

# AGENCY:

Centers for Medicare & Medicaid Services, Department of Health and Human Services.

# ACTION:

Notice.

# 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 February 20, 2018.

# ADDRESSES:

                        When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806                         *OR*, Email:                         *OIRA_submission@omb.eop.gov*.                    

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.*

                        2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to                         *Paperwork@cms.hhs.gov.*

3. Call the Reports Clearance Office at (410) 786-1326.

# 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 without change of a previously approved collection;                     *Title of Information Collection:*                     New Technology Payments for APCs Under the Outpatient Prospective Payment System;                     *Use:*                     CMS needs to keep pace with emerging new technologies and make them accessible to Medicare beneficiaries in a timely manner. It is necessary that we continue to collect appropriate information from interested parties such as hospitals, medical device manufacturers, pharmaceutical companies and others that bring to our attention specific services that they wish us to evaluate for New Technology APC payment. We are making no changes to the information that we collect. The information that we seek to continue to collect is necessary to determine whether certain new services are eligible for payment in New Technology APCs, to determine appropriate coding and to set an appropriate 4 payment rate for the new technology service. The intent of these provisions is to ensure timely beneficiary access to new and appropriate technologies.                     *Form Number:*                     CMS-10054 (OMB control number: 0938-0860);                     *Frequency:*                     Annually;                     *Affected Public:*                     Private Sector (Business or other For-profits);                     *Number of Respondents:*                     10;                     *Total Annual Responses:*                     10;                     *Total Annual Hours:*                     160. (For policy questions regarding this collection contact Joshua McFeeters at 410-786-9732).                

                    2.                     *Type of Information Collection Request:*                     Revision of a currently approved collection;                     *Title of Information Collection:*                     Report of a Hospital Death Associated with Restraint or Seclusion;                     *Use:*                     The regulation that was published on May, 16, 2012 (77 FR 29074) included a reduction in the reporting requirement related to hospital deaths associated with the use of restraint or seclusion, § 482.13(g). Hospitals must use Form CMS-10455 to report those deaths associated with restraint and/or seclusion directly to the Centers for Medicare & Medicaid Services (CMS) Regional Office (RO). This requirement also applies to rehabilitation or psychiatric distinct part units (DPUs) in Critical Access Hospitals (CAHs). The RO must provide hospitals with instructions for submitting the form fax and/or email, based on RO preference. Hospitals are no longer required to report to CMS those deaths where there                           ( print page 2785)                        was no use of seclusion and the only restraint was 2-point soft wrist restraints beginning in May 9, 2014. This reporting requirement change resulted in no necessary edits to the form CMS-10455 as soft wrist restraints may be used in combination with other types of restraints. It was estimated that this would 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.                

                    Form CMS-10455 is being revised in order to obtain the necessary information for the ROs to make a determination whether or not to authorize an on-site investigation related to the details surrounding the death of individuals associated with restraint and/or seclusion.                     *Form Number:*                     CMS-10455 (OMB control number: 0938-1210);                     *Frequency:*                     Occasionally;                     *Affected Public:*                     Private Sector;                     *Number of Respondents:*                     6,389;                     *Number of Responses:*                     6,389;                     *Total Annual Hours:*                     2,619. (For policy questions regarding this collection contact Karina Meushaw at 410-786-1000.)                

Dated: January 12, 2018.

Martique Jones,

Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs.

[FR Doc. 2018-00834 Filed 1-18-18; 8:45 am]

 BILLING CODE 4120-01-P