[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