[Federal Register Volume 84, Number 107 (Tuesday, June 4, 2019)]
[Notices]
[Pages 25810-25811]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11630]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10697]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

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

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 August 5, 2019.

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.

[[Page 25811]]

    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 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 [email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.

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-10697 Medicare Coverage of Items and Services for Coverage With 
Evidence Development

    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: New collection (Request 
for a new OMB control number); Title of Information Collection: 
Medicare Coverage of Items and Services for Coverage with Evidence 
Development; Use: CED is a paradigm whereby Medicare covers items and 
services on the condition that they are furnished in the context of 
approved clinical studies or with the collection of additional clinical 
data. In making coverage decisions involving CED, CMS decides after a 
formal review of the medical literature to cover an item or service 
only in the context of an approved clinical study or when additional 
clinical data are collected to assess the appropriateness of an item or 
service for use with a particular beneficiary. When an NCD requires CED 
under 1862(a)(1)(E), it is because the available evidence about a 
particular item or service is insufficient to support coverage outside 
the context of a well-designed clinical research study. Sponsors could 
build interim analyses and final analyses into their study design and 
communicate these results to CMS.
    Section 1142 of the Act describes the authority of the Agency for 
Healthcare Research and Quality (AHRQ) to conduct and support research 
on outcomes, effectiveness, and appropriateness of services and 
procedures to identify the most effective and appropriate means to 
prevent, diagnose, treat, and manage diseases, disorders, and other 
health conditions. That section includes a requirement that the 
Secretary assure that AHRQ research priorities under Section 1142 
appropriately reflect the needs and priorities of the Medicare program.
    The coordination of AHRQ priorities under section 1142 with the 
needs and priorities of the Medicare program is accomplished through 
direct collaboration between the AHRQ and CMS. AHRQ reviews all CED 
NCDs established under Section 1862(a)(1)(E) of the Act. Consistent 
with section 1142, AHRQ also indicates its support for clinical 
research studies that CMS determines address the CED questions and meet 
the general standards for CED studies. In order for CMS (or its 
designated entity) to determine if the Medicare coverage criteria are 
met, as described in our regulations, CMS (or its designated entity) 
must review the study protocol and supporting materials, as needed. 
Form Number: CMS-10697 (OMB control number: 0938-New); Frequency: 
Yearly; Affected Public: Private Sector (Business or other for-profits, 
Not-for-Profit Institutions); Number of Respondents: 15; Total Annual 
Responses: 15; Total Annual Hours: 15,000. (For policy questions 
regarding this collection contact Xiufen Sui at 410-786-3136.)

    Dated: May 30, 2019,
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2019-11630 Filed 6-3-19; 8:45 am]
BILLING CODE 4120-01-P