Frontlines – News Trends Legislation

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    In the Loupe
    Dynamic Stabilization: Placement of a pedicle-based motion preservation device, the Stabilimax NZ [Applied Spine Technologies, New Haven, Conn.] (far left), at L4-5 as seen on the postoperative lateral radiograph. The patient is a 63-year-old woman with 20 years of low back pain and recent hip and lower extremity pain. Preoperative imaging revealed a grade I L4-5 spondylolisthes is and lateral recess stenosis refractory to conservative treatment. Surgery consisted of bilateral laminoforaminotomies and placement of the device, the goal of which is to reduce spinal motion to a more normal physiological range. (Contributed by Andrew T. Dailey, MD, Salt Lake CIty,  Utah. Dr. Dailey reported no conflicts for disclosure.)

    Medicare Options for Physicians: Impact of Medicare, Medicaid and SCHIP Extension Act of 2007Congress passed legislation in late December 2007
    that gave physicians a 0.5 percent payment increase from Jan. 1 through June 30, 2008, temporarily cancelling a 10.1 percent cut that was scheduled to take effect Jan. 1. Congress financed this temporary reimbursement increase in such a way that, in the absence of congressional action, the payment cut in July will be about 10.6 percent. The Congressional Budget Office now estimates that the cut in 2009 will be approximately 5 percent. In light of the passage of the Medicare, Medicaid and SCHIP Extension Act of 2007, the Centers for Medicare and Medicaid Services reopened the Medicare participation decision period for an additional 45 days to Feb. 15, with all participating status changes effective Jan. 1. The document Medicare Participation Options for Physicians, developed by the AANS and the Congress of Neurological Surgeons outlines the various Medicare participation options available to physicians. www.aans.org/legislative/aans/medical.asp
    Get In the Loupe. Compelling digital photos that depict a contemporary event or clinical topic or technique in neurosurgery are sought for In the Loupe. Submit a low resolution image in JPG format to [email protected] with “In the Loupe” in the subject line and a brief description of the photo and its significance in the e-mail message. Submitters must verify copyright ownership of the image and have a 300 DPI resolution image available for publication

    Medical Liability Rates Improve Nationwide
    Medical liability insurance rates are easing nationwide for the second straight year, reported American Medical News. Citing a survey in Medical Liability Monitor, a publication which tracks medical liability rates, it reported that nearly 84 percent of company-reported rates held steady or decreased in 2007. More than half of premiums did not change, nearly one third declined, and increases were slowing, but premiums were still considered high. Further, while the frequency of lawsuit filings decreased, the number of large claims increased as did litigation expenses. www.ama-assn.org/amednews/2007/12/17/prl11217.htm

    Most Medical School Chairs Have Industry Ties
    A national survey of medical school department chairs revealed that almost two-thirds had some form of personal relationship with industry, including serving as a consultant (27 percent), a member of a scientific advisory board (27 percent), a paid speaker (14 percent), an officer (7 percent), a founder (9 percent), or a member of the board of directors (11 percent). Campbell and colleagues found that two-thirds of departments as administrative units had relationships with industry. Clinical departments were more likely than nonclinical departments to receive research equipment, unrestricted funds, residency or fellowship training support, and continuing medial education support, but nonclinical departments were more likely to receive funding from intellectual property licensing. More than two-thirds of chairs perceived that having a relationship with industry had no effect on their professional activities. JAMA 298(15): 1779-86, 2007

    Device Fragments Can Trigger Serious Adverse Events
    The FDA warned of serious adverse events, nearly 1,000 annually, associated with unretrieved device fragments. The January 2008 notification reported adverse events including local tissue reaction, infection, perforation and obstruction of blood vessels, and death. The FDA cited biocompatibility of the device materials, location of the fragment, potential migration of the fragment, and patient anatomy, among the contributing factors. It further noted that during MRI procedures magnetic fields may cause metallic fragments to migrate and radiofrequency fields may cause them to heat, causing internal tissue damage and/or burns. The FDA cautioned usage of medical devices in accordance with their labeled indications and the manufacturer’s instructions for use, particularly during insertion and removal. Recommendations included: inspection of devices prior to use for damage during shipment or storage or any out-of-box defects that might increase the likelihood of fragmentation during a procedure; inspection of devices immediately upon removal from the patient for any signs of breakage or fragmentation; retention of damaged devices to assist with the manufacturer’s analysis of the event; and disclosure to and discussion with the patient of the risks and benefits of
    retrieving or leaving the fragment in the patient.
    www.fda.gov/cdrh/safety/011508-udf.html

    New Web Site Promotes Healthcare as a Marketplace
    A Web site launched in January 2008 offers consumers the ability to compare healthcare services like they might shop for cars or travel at sites such as Cars.com and Travelocity.com. Carol.com, named to evoke the persona of a trusted neighbor, compares doctors, prices, location, credentials and availability. For example, a search on the keyword “brain” presents listings that include “care packages” for brain CT, brain MRI, and brain cancer evaluation. Results for a search on “spine” include similar diagnostic tests as well as packages that address types of pain experienced (chronic neck pain with or without arm pain; chronic back pain with or without leg pain). Site users can review the packages as well as providers that are offering the services, book appointments, and share their healthcare experiences in the “community” area of the site. The site currently focuses on Minneapolis and St. Paul, Minn., with plans to expand to other markets in 2008. www.carol.com

    FDA Authority Over Medical Devices Expanded
    The Food and Drug Administration Amendments Act of 2007, H.R. 3580, passed by Congress in late September 2007, expanded the FDA’s role in reviewing, approving and monitoring medical devices. The FDAAA also reauthorized aspects of the Medical Device User Fee and Modernization Act of 2002 through 2012, including the medical device user fee program. In addition, the FDAAA provides several incentives for manufacturers, including those for development of pediatric devices. https://thomas.loc.gov

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