[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)]
[Notices]
[Pages 11571-11572]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04861]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10152]
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 require; 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 May 3, 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-10152 Data Collection for Medicare Beneficiaries Receiving NaF-18
Positron Emission Tomography (PET) To Identify Bone Metastasis in
Cancer
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.
1. Type of Information Collection Request: Extension of a
previously approved collection; Title: Data Collection for Medicare
Beneficiaries Receiving NaF-18 Positron Emission Tomography (PET) to
Identify Bone Metastasis in Cancer; Use: In Decision Memorandum #CAG-
00065R, issued on February 26, 2010, the Centers for Medicare and
Medicaid Services (CMS) determined that the evidence is sufficient to
conclude that for Medicare beneficiaries receiving NaF-18 PET scan to
identify bone metastasis in cancer is reasonable and necessary only
when the provider is participating in and patients are enrolled in a
clinical study designed to information at the time of the scan to
assist in initial antitumor treatment planning or to guide subsequent
treatment strategy by the identification, location and quantification
of bone metastases in beneficiaries in whom bone metastases are
strongly suspected based on clinical symptoms or the results of other
diagnostic studies. Qualifying clinical studies must ensure that
specific hypotheses are addressed; appropriate data elements are
collected; hospitals and providers are qualified to provide the PET
scan and interpret the results; participating hospitals and
[[Page 11572]]
providers accurately report data on all Medicare enrolled patients; and
all patient confidentiality, privacy, and other Federal laws must be
followed. Consistent with section 1142 of the Social Security Act (the
Act), the Agency for Healthcare Research and Quality (AHRQ) supports
clinical research studies that CMS determines meets specified standards
and address the specified research questions. To qualify for payment,
providers must prescribe certain NaF-18 PET scans for beneficiaries
with a set of clinical criteria specific to each solid tumor. The
statuary authority for this policy is section 1862(a)(1)(E) of the Act.
The need to prospectively collect information at the time of the scan
is to assist the provider in decision making for patient management.
Form Number: CMS-10152 (OCN: 0938-0968); Frequency: Annual; Affected
Public: Private Sector (Business or other for-profits); Number of
Respondents: 25,000; Total Annual Responses: 25,000; Total Annual
Hours: 2,084 hours. (For policy questions regarding this collection
contact Stuart Caplan at 410-786-8564.)
Dated: March 1, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2016-04861 Filed 3-3-16; 8:45 am]
BILLING CODE 4120-01-P