“June 3, 2002 Intelligence: Late Breaking Lab News”

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Medicare fraud investigators may not be getting big headlines in recent years, but they are collecting ever-growing amounts of money from healthcare fraud settlements, judgements, and impositions. A record $1.36 billion was collected in 2001. During the year, federal investigators filed 445 criminal indictments and 188 healthcare fraud cases. Some observers believe fraud enforcement efforts may be lessened in the aftermath of 9/11 as federal agencies devote more resources to fighting terrorism.

FDA APPROVES HIV RESISTANCE SOFTWARE

In less than 30 days, Visible Genetics Inc. gained Food & Drug Administration review and clearance for its next generation of software for interpreting HIV drug resistance from results of its TRUGENE™ HIV-1 Genotyping test. Each update includes information about new drugs and mutating strains of HIV-1 that are developing resistance to specific drugs.

ORASURE GAINS FDA APPROVAL FOR QUICK HIV-1 TEST

Subject to the company meeting certain conditions, the Food and Drug Administration (FDA) has notified OraSure, Inc . that its Ora-Quick® Rapid HIV-1 Antibody test is approvable. This test uses a finger-stick sample of whole blood and will detect HIV-1 antibodies in ten minutes. OraSure is best known for its oral fluid test for HIV-1, which has met with ready acceptance in many prominent AIDS clinics in the United States. It is also used in life insurance testing. By developing a whole blood test for HIV-1 using its proprietary technology, OraSure hopes to open a wider market by enabling point-of-care screening for HIV-1.

HOSPITAL C.O.N.S

Look for certificates of need (CON) to become a hot issue in certain states as hospitals respond to increasing admissions rates with plans to expand their facilities. The CON approval process will attract opposition from competing hospitals seeking to block new competition. Large employers may also get involved. Testifying before a Michigan state panel last March, executives from DaimlerChrysler AG testified in favor of retaining the state’s CON laws. Daimler-Chrysler offered some interesting statistics. In Michigan and New York, it spends $1,839 and $1,331 per employee or family member per year on healthcare. These are states with CON laws. In Wisconsin and Indiana, Chrysler pays $3,519 and $2,741, respectively, per person for healthcare. These are states without CON laws.

“Better” Marker For Prostate Cancer?

Researchers at the University of Michigan Medical School discovered a new genetic marker for prostate cancer which they believe is more accurate than prostate specific antigen (PSA). The gene expresses a protein enzyme called a-methylacyl-CoA racemase (AMACR). It is present only in malignant cells and is visible when stained. Their study was published in the April 3 issue of the JAMA.

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