[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: 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 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: 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 [email protected], 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