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Leading the News
FDA Panel: Imaging Agents Could Aid Alzheimer's Diagnosis
Imaging agents currently in development for the detection of amyloid plaques could improve early Alzheimer's diagnosis, according to a Food and Drug Administration Panel of outside experts. Currently, Bayer Healthcare Pharmaceuticals, GE Healthcare, and Avid Pharmaceuticals are developing imaging agents designed to detect amyloid plaques associated with Alzheimer's disease using positron-emission tomography (PET) scans. The companies recently sought advice from the FDA panel regarding clinical trial design for such imaging agents. According to Rafel Rieves, director of the FDA's medical imaging office, the agency wants to create guidance for the companies to follow in order to ensure the trials are safe and effective.
From "FDA Panel: Imaging Agents Could Aid Alzheimer's Diagnosis"
Wall Street Journal (10/23/08) Dooren, Jennifer Corbett
Research
Localization Aids Optimize Prostate Cancer Therapy
Localization aids, such as ultrasound systems, are essential to optimize radiation therapy for prostate cancer according to a study conducted Atomic Institute of Austrian Universities Prof. Karin Polijanc and her team. The researchers used ultrasound examinations to pinpoint the location of patient's organs prior to radiation treatment. They then analyzed the positioning of 60 patients, evaluating the deviation of radiation in various spatial directions. They found that although time consuming, the use of ultrasound makes shifts in organ position caused by minimal patient movement both visible and traceable.
From "Optimized Radiation for Prostate Cancer Therapy"
Science Centric (10/17/2008)
BI-RADS Subcategories Improve Diagnostic Accuracy in Mammographic Reports
University of Louisville researchers have found that the use of Breast Imaging and Reporting Data System (BI-RADS) subcategories by radiologists can help improve the accuracy of breast cancer diagnoses. The results of the study, were presented by lead researcher Dr. Mary Ann Sanders at the American Society for Clinical Pathology Annual Meeting. For the purposes of their research, Dr. Sanders and her team analyzed 239 breast biopsies to determine whether using subcategories for BI-RADS level 4 could improve diagnosis. According to the American College of Radiology, approximately 30 percent of BI-RADS level 4 lesions turn out to be malignant. To better assess which lesions may be malignant BI-RADS subcategories A,B, and C, were established, with C representing the most suspicious lesions and A the least suspicious. Of the 24 lesions found by Dr. Sanders and her team to be BI-RADS level 4C, 71 percent were ductal carcinoma in situ. In contrast, just 11 percent of the 94 BI-RADS 4A and 21 percent of the 73 BI-RADS 4B cases were ductal carcinoma in situ. Without subcategorization, only 23 percent of carcinomas were detected in the total 239 cases of BI-RADS 4.
From "Breast Imaging Reporting Data System Subcategories Improve Diagnostic Accuracy in Mammographic Reports: Presented at ASCP"
Doctor's Guide (10/17/08)
Technology
Early Stage Tumors Targeted by Improved Ultrasound Agents, Techniques
European researchers are in the process of developing improved ultrasound contrast agents and imaging techniques designed to improve the sensitivity of ultrasound in the detection of early-stage tumors. Researchers in the EU-funded TAMIRUT project have developed a microbubble medium that can specifically target and bind to certain pathogenic cells including endothelial cells of vessels lining tumors. When combined with wide-frequency ultrasound equipment and signal processing capabilities, the imaging agent can detect tiny quantities of pathological tissue.
From "Sensitive Ultrasound to Spot Early-Stage Cancer"
PhysOrg.com (10/23/08)
Practice Management and EMR Systems Prompt Data Storage Questions
Physicians must consider whether to purchase, implement, and maintain practice management and electronic medical records systems on their own in-house servers or contract with a third-party host, or ASP. With an ASP, the vendor maintains the software, database, and hardware in a central location, and practice staff access the systems via the Internet. With regard to clinic workflow, both models perform similarly. However, physicians have a lot to think about when it comes to acquisition, maintenance, and upgrades. With an ASP, practices need only purchase workstations with Internet connections, while those opting for the client-server model must purchase the server, the workstations, and all the hardware and software upfront. As for connectivity and remote access, the ASP model lets users access systems over the Internet, and while the quality of the Internet connection is a concern, these practices do not have to purchase and install client software or ensure adequate bandwidth. Practices embracing the ASP model have access to upgraded software as soon as the vendor makes it available, but under the client-server model, practices have to purchase upgraded applications and add memory as necessary. Backup and recovery is part of the ASP package, but practices embracing the client-server model will have to purchase the necessary backup software and ensure employees perform regular backups. Experts note that practices without a lot of upfront cash might want to consider the ASP model.
From "To ASP or Not to ASP?"
MedPage Today (09/30/08) Nelson, Rosemarie
Medical-Legal Issues
Medicare Battle Looms as Costs Keep Climbing
Democratic legislators in Congress are getting ready for a major campaign over Medicare in 2009 that could create significant changes, including reductions in payments to private insurers that provide Medicare coverage and a new right for the U.S. government to negotiate prescription prices. Both Sens. John McCain (R-Ariz.) and Barack Obama (D-Ill.) support enacting improved technology. Congress is set to discuss a scheduled reduction in physicians' fees for Medicare that would go into effect at 2009's end. The fee matter could create opportunities for Democrats to make larger changes to the program. Around 9.4 million Americans, or 21 percent of all Medicare recipients, take part in private Medicare Advantage plans, claims a June report from the Medicare Payment Advisory Commission, while in Medicare Advantage, individuals get their benefit via a private insurer rather than right from the government. The commission estimated that 2008 payments to the private plans would be 13 percent more than what the government would have spent on direct coverage, resulting in around $10 billion of additional government spending.
From "Medicare Battle Looms as Costs Keep Climbing"
Wall Street Journal (10/29/08) P. A4; Matthews, Anna Wilde
Legality of EMRs an Increasing Concern
The legality of electronic medical records (EMR) is becoming a concern as an increasing number of physicians implement the technology. Physicians must be aware of their liabilities under the Federal Rules of Civil Procedure, which make any electronically stored data discoverable in a trial. Dr. Reed Gelzer, co-founder of Advocates for Documentation Integrity and Compliance, says combining EMRs with metadata enhances accuracy, but physicians must be aware that some systems red-flag Health Insurance Portability and Accountability Act (HIPAA) violations and that not every system produces medical records that meet the legal definition. EMRs standards and certifications are in the works, and vendors could create systems that meet HIPAA requirements and civil procedure laws. The Certification Commission for Healthcare Information Technology (CCHIT) issued its first EMR certification criteria two years ago, but Gelzer says the criteria "still isn't comprehensive enough to relieve physicians of any due diligence responsibility [when searching for a system]." According to Gelzer, HIPAA auditing mandates that all versions of a record be retrieved, but CCHIT certification does not require that a copy of the original document be saved. When selecting an EMR, Gelzer says the system should name the individuals responsible for entering the different parts of the record, track changes made to the record, take note of who made the changes and when, save the original copy, and include an audit function with cross-checking capabilities.
From "Is Your EMR Legal? A Document Can Look Like a Medical Record, But Not Meet the Legal Definition"
American Medical News (10/13/08) Dolan, Pamela Lewis
Malpractice Rate Changes May Not Affect Overall Healthcare Costs
Advocates of medical malpractice reform often say limiting damage awards for healthcare negligence are a way to curb high insurance costs and eliminate frivolous litigation. Additionally, many advocates say that limiting damage awards will reduce malpractice premiums for physicians, which will stem healthcare provider losses in many states. Meanwhile, tort reform advocates also indicate that insurers are price-gouging physicians even though medical malpractice payouts have been stable over the last couple of decades. In those states where tort reforms were passed, physicians have complained their malpractice rates have not fallen or have dropped very little. The American Insurance Association (AIA) states, "Insurers never promised that tort reform would achieve specific premium savings." The Congressional Budget Office recently reported that malpractice costs account for less than 2 percent of overall healthcare spending, and up to a 30 percent malpractice premium reduction would not lower health insurance premiums by even 0.5 percent.
From "The Truth About Medical Negligence"
Injury Board (10/27/2008) Parsons, Wayne
Clinical Practice
Ethics Critical to Billing and Collections
At a time when patients are underinsured and consumer-directed health insurance is gaining ground, physicians must rely on professional ethics when developing and executing their billing and collections services. There are two models of professionalism in conflict when physicians seek payments from patients; transactional models dictate that patients pay for services rendered by providers at the price charged, while relational models find medical services intertwined with the therapeutic relationship between provider and patient. In today's system, physicians and other providers are forced to aggressively collect payments from under or uninsured patients, with providers requiring an upfront payment before procedures are performed. Most ethical guidelines for providers only stipulate that patient duties supersede compensation concerns, though no specific guidance is offered. Physicians have stopped offering discounts to uninsured patients, and others are less likely to offer appointments to uninsured patients. The American Medical Association urges providers to remain compassionate and waive co-payments for those seeking care. Ethically, providers should offer care to all patients in need, and only drop patients when alternative means of care are available. Experts suggest providers offer extended repayment terms and write off medical losses rather than hire a collection agency.
From "The Professional Ethics of Billing and Collections"
Journal of the American Medical Association (10/15/08) Vol. 300, No. 15, P. 1806; Hall, Mark A.; Schneider, Carl E.
Industry News
IAEA Meets to Discuss Patient Safety Improvement
The International Atomic Energy Agency (IAEA) recently held its first meeting to discuss the impact of new imaging and radiation therapy technologies on patient safety. The IAEA estimates that there are approximately 4 billion x-ray examinations, 30 million nuclear medicine examinations, and 5 million patients undergoing radiotherapy annually. There is no accurate record of how much radiation patients are exposed to through the process of diagnosis and treatment, but according to a report by the United Nations Scientific Committee on the Effects of Atomic Radiation, patients are exposed to approximately 200 times more ionizing radiation than medical workers. In some countries, the figure was nearly 500 times. The IAEA is currently heading studies in 82 member states designed to reduce patient radiation doses without compromising diagnostic information or image quality. Additionally, an IAEA team, led by radiation specialist Dr. Madan Rehani, is developing a card that would record information about the radiation doses a patient receives. Dr. Rehani's team is scheduled to meet for the first time in 2009. Over the next three years, they will focus on the minimum radiation quantities to be measured by the device as well as guidelines, norms, disclaimers, and security issues related to the use of the card.
From "When the Ill Need Protection From the Cure: Effect of Ionizing Radiation on Patients Addressed"
Science Daily (10/17/08)
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