Health Imaging & IT - June 2008 - (Page 6)

NEWS UPDATE Government Watch FDA examines warning letter appeal process for medical device makers The FDA is reviewing its procedures for the appeal and dispute process. Reps. Joe Barton, R-Texas, and John Shimkus, R-Ill., sent a letter to FDA Commissioner Andrew von Eschenbach, questioning the agency’s practice of telling companies they can appeal a decision when it intends to proceed with enforcement actions. The FDA said it will follow up with House Oversight and Investigations Subcommittee staff to discuss details of its new internal operating guidelines and other steps taken in response to lawmakers’ concerns.  FDA SPOTLIGHT FDA sends Philips warning letter for CT, nuclear imaging The FDA issued a warning to Philips Medical Systems about problems with manufacturing procedures for its CT and nuclear imaging systems, including failures to oversee proper device design and proper procedures to handle complaints.  CMS seeks comment on CT colonography coverage CMS has initiated a national coverage analysis for the use of screening CT colonography (CTC) for colorectal cancer, which will evaluate the available evidence for screening CTC and determine if a National Coverage Determination is warranted. CMS said that it is particularly interested in clinical studies and other scientific information related to the technology under review, which can be submitted at www.cms.hhs.gov. Image: TeraRecon FDA greenlights GE Healthcare surgery unit; shipping resumes The FDA in May allowed GE Healthcare’s surgery unit to resume operations and begin shipping its OEC 9900 Elite C-arm fluoroscopy device. The approval marked the end of a 20-month shutdown that stemmed from the FDA’s finding that device malfunctions were not being reported. Medicare could cover remote monitoring Rep. Anna Eshoo, D-Calif., along with seven other bipartisan co-sponsors, introduced the Medicare Remote Monitoring Access Act of 2008, which proposes Medicare be required to cover remote monitoring services for patients with chronic health conditions. The bill, H.R. 5765, proposes to amend title XVIII of the Social Security Act to cover remote patient management.  FDA sends Xoran warning letter over CT scanner The FDA sent Xoran Technologies a warning letter concerning its MiniCat Scanner, a compact, volume CT scanner of the sinuses, skull base and temporal bones. Bush administration guards Medicare database The administration of President George W. Bush is appealing a court ruling that would permit disclosure of Medicare billing records that would allow patients to compare doctors’ expertise and efficiency. Consumer groups, employers and the health insurance industry are advocating for the release of the database, but the ruling is opposed by organizations representing doctors. The Medicare claims database holds information on more than 40 million patients and 70,000 doctors. With more than 40 million patients and 700,000 doctors, the Medicare claims database holds the most U.S. healthcare data. 6 Health Imaging & IT | June 2008 NRC seeks to track 20,000 more radioactive sources, licensees The Nuclear Regulatory Commission (NRC) is proposing to expand its National Source Tracking System (NSTS) to include an additional 3,500 NRC and state licensees and nearly 17,000 additional radioactive sources, to improve accountability and control of radioactive materials. The proposed rule has been published in the Federal Register, and would require the additional licensees to report information on the manufacture, transfer, receipt, disassembly and disposal of these radioactive sources to the NSTS. Manufacturers will be required to assign a unique serial number to each nationally tracked source.  CMS, FDA launch initiative to improve safety of medical devices, drugs The FDA and the CMS have begun the Sentinel Initiative, which will include the development of a new electronic system, enabling the FDA to query an array of information to identify possible post-market adverse events. The Sentinel System will be created through public-private partnerships and will capitalize on existing electronic claims and medical records data sources maintained by participating private and government entities. STAY CONNECTED: For daily news, log onto HealthImaging.com HealthImaging.com http://www.cms.hhs.gov http://HealthImaging.com http://HealthImaging.com

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Health Imaging & IT - June 2008 Contents On The Web The Enterprise News Update Cover Story: Pushing Productivity: How Imaging is Building Efficiency and Cutting Costs Technology Outlook: Imaging Procedures Poised for Growth Great Expectations: PET/CT Delivers SPECT/CT Proving it's Potential MR/PET Holds Promise Good Image Management: Infiltrating Molecular Imaging SNM Preview Modality Review: Mammography’s Next Step: The Dawning of Breast Tomosynthesis Managing Technology: Radiation Oncology: Opening the Doors to IT Reader's Resource Stat Sheet

Health Imaging & IT - June 2008

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