3.Type of Information Collection Request:Reinstatement 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 bonemetastases 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.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. (For policy questions regarding this collection contact Stuart Caplan at 410-786-8564. For all other issues call 410-786-1326.)
4.Type of Information Collection Request:Reinstatement of a currently approved collection;Title:Medicare Program: Procedures for Making National Coverage Decisions;Use:The Centers for Medicare & Medicaid Services (CMS) revised the April 27, 1999 (64 FR 22619) notice and published a new notice on September 26, 2003 (68 FR 55634) that described the process we use to make Medicare coverage decisions including decisions regarding whether new technology and services can be covered. We have made changes to our internal procedures in response to the comments we received following publication of the 1999 notice and experience under our new process. Over the past several years, we received numerous suggestions to further revise our process to continue to make it more open, responsive, and understandable to the public. We share the goal of increasing public participation in the development of Medicare coverage issues. This will assist us in obtaining the information we require to make a national coverage determination in a timely manner and ensuring that the Medicare program continues to meet the needs of its beneficiaries.Form Number:CMS-R-290 (OCN: 0938-0776);Frequency:Annual;Affected Public:Private Sector: Business or other for-profits;Number of Respondents:200;Total Annual Responses:200;Total Annual Hours:8,000. (For policy questions regarding this collection contact Katherine Tillman at 410-786-9252. 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 address athttp://www.cms.hhs.gov/PaperworkReductionActof1995,or Email your request, including your address, phone number, OMB number, and CMS document identifier, toPaperwork@cms.hhs.gov,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 byOctober 9, 2012:
1.Electronically.You may submit your comments electronically tohttp://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.