[Federal Register Volume 75, Number 199 (Friday, October 15, 2010)]
[Notices]
[Page 63484]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-25934]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-R-153 and CMS-10152]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, HHS.
    In compliance with the requirement of section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid 
Services (CMS) is publishing the following summary of proposed 
collections for public comment. Interested persons are invited to send 
comments regarding this burden estimate 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.
    1. Type of Information Collection Request: Reinstatement with 
change of a previously approved collection; Title of Information 
Collection: Medicaid Drug Utilization Review (DUR) Annual Report; Use: 
The DUR program is required to assure that prescriptions are 
appropriate, medically necessary and are not likely to result in 
adverse medical results. Each State DUR program must consist of 
prospective drug use review, retrospective drug use review, data 
assessment of drug use against predetermined standards, and ongoing 
educational outreach activities. In addition, States are required to 
submit an annual DUR program report that includes a description of the 
nature and scope of State DUR activities as outlined in the statute and 
regulations. Over the years, technology has changed as has the practice 
of the pharmacy. Therefore, CMS has revised the old survey vehicle to 
more fully address the current practices and areas of concern with the 
Medicaid Pharmacy Programs. Form Number: CMS-R-153 (OMB<greek-i>: 0938-
0659); Frequency: Annually; Affected Public: State, Local, or Tribal 
Governments; Number of Respondents: 51; Total Annual Responses: 51; 
Total Annual Hours: 20,298. (For policy questions regarding this 
collection contact Madlyn Kruh at 410-786-3239. For all other issues 
call 410-786-1326.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Data Collection 
for Medicare Beneficiaries Using NaF-18 Positron Emission Tomography 
(PET) to Identify Bone Metastasis in Cancer; Use: In Decision 
Memorandum <greek-i> 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 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 Agency for Healthcare Research and Quality (AHRQ) supports clinical 
research studies that the CMS determines meet 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 Social Security Act. The need to prospectively 
collect information at the time of the scan is to assist the provider 
in decision making for patient management. 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. Data 
elements will be transmitted to CMS for evaluation of the short and 
long-term benefits of NaF-18 PET to beneficiaries and for use in future 
clinical decision making. Form Number: CMS-10152 (OMB<greek-i>: 0938-
0968); Frequency: Annually; Affected Public: Individuals or Households; 
Number of Respondents: 25,000; Total Annual Responses: 25,000; Total 
Annual Hours: 2,084. (For policy questions regarding this collection 
contact Stuart Caplan at 410-786-9564. For all other issues call 410-
786-1326.)
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access CMS' 
Web site at http://www.cms.hhs.gov/PaperworkReductionActof1995, or e-
mail your request, including your address, phone number, OMB number, 
and CMS document identifier, to <a href="/cdn-cgi/l/email-protection#217140514453564e534a61424c520f4949520f464e57"><span class="__cf_email__" data-cfemail="5d0d3c2d382f2a322f361d3e302e7335352e733a322b">[email protected]</span></a>, or call the 
Reports Clearance Office on (410) 786-1326.
    In commenting on the proposed information collections please 
reference the document identifier or OMB control number. To be assured 
consideration, comments and recommendations must be submitted in one of 
the following ways by December 14, 2010:
    1. Electronically. You may submit 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) 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.

    Dated: October 8, 2010.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. 2010-25934 Filed 10-14-10; 8:45 am]
BILLING CODE 4120-01-P


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