CMS accepts EXACT's cancer coverage application

EXACT Sciences (Marlborough, Massachusetts) said that the Centers for Medicare & Medicaid Services (CMS; Washington) has accepted its application requesting a national coverage determination for the company's DNA-based colorectal cancer (CRC) screening technologies. While there is typically a nine- to twelve-month statutory period from application acceptance to a final CMS coverage determination, CMS has indicated that it expects to complete the national coverage analysis by May 1, 2008.

Medicare beneficiaries include 43 million of the approximately 87 million people in the U.S. over age 50 for whom regular screening is recommended. Claims data from 1998-2002 suggest that only about 31% of Medicare beneficiaries have ever had a CRC screening test. Moreover, since 69% of newly diagnosed cases of CRC occur in people aged 65 and older, Medicare assumes a significant portion of the costs associated with CRC treatment.

EXACT Sciences uses applied genomics to develop screening technologies for use in the detection of cancer.

U-Systems launches new web site

U-Systems (San Jose, California) reported the launch of a new web site in women's health and breast imaging, Breast ultrasound has long been established as a preferred modality for diagnostic breast imaging, especially in women with dense breasts. Dense breast tissue is a major contributor to missed cancers by X-ray mammography. Ultrasound can penetrate dense breast tissue and provide high quality images to detect cancers that cannot be seen by conventional X-ray mammography. With the advent of U-Systems automated breast ultrasound with SomoSynthesis, the company said that radiologists now have standardized, reproducible, 3-D views of the breast enabling improved diagnostic confidence.

SomoSynthesis combines wide field of view, automated image acquisition with advanced 3-D image reconstruction and interpretation. The result, according to the company, is better tissue visualization, especially in the coronal view. This combination of acquisition and review makes possible standardized, reproducible breast ultrasound patient studies and significant improvements in workflow efficiencies.

U-Systems makes automated ultrasound systems.

CardioDynamics allowed expanded ICG coverage

CardioDynamics (San Diego) reported that two contractors for the Centers for Medicare and Medicaid Services (CMS) recently made changes to their coverage policies that allowed expanded coverage of ICG for patients with high blood pressure, also referred to as hypertension. The involved local contractors provide coverage for patients in Mississippi, Alabama, Georgia and South Carolina. These states are known for having higher rates of hypertension in the U.S. and have struggled to find innovative means of treating and controlling hypertensive patients. The new local coverage allows treatment for resistant hypertension (uncontrolled blood pressure on three or more drugs) and complements the currently covered national indications, including heart failure, shortness of breath, and pacemaker optimization.

CardioDynamics makes BioZ impedance cardiography technology.

Cleveland Clinic uncovers new HDL findings

Researchers at the Cleveland Clinic (Cleveland, Ohio) have identified the region within high density lipoprotein (HDL), the major carrier of “good” cholesterol, that can become dysfunctional within the artery wall, inhibiting the body's ability to fight cholesterol buildup.

The findings are important because raising HDL levels represents a major target for new treatment strategies of atherosclerosis, the accumulation of harmful plaque in the arteries, by the pharmaceutical industry. Yet it appears that the function as well as the level of the HDL is important. This may also help explain research earlier this year which found that despite raising the level of HDL (good) cholesterol, the drug torcetrapib did not slow the progression of artery disease.

Cleveland Clinic is a not-for-profit multispecialty academic medical center that integrates clinical and hospital care with research and education.

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