News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Do Some Clinical Laboratory Companies Oversell Prenatal Genetic Screening Tests?

A growing number of media stories claim medical lab companies that develop genetic screening assays oversell the accuracy of such tests and fail to educate parents and doctors about the risks of false positives and false negatives

In response to growing concerns by consumers about the accuracy of some proprietary genetic screening assays, several media outlets have begun reporting on this sector of the clinical laboratory industry.

What gives these news stories emotional punch is the fact that patients use these proprietary medical laboratory tests to make decisions that can be life-changing. In its story about these tests, the Boston Sunday Globe used the headline “Oversold prenatal tests spur some to choose abortions.” (more…)

Palmetto GBA Execs Explain MolDx, Its New “Molecular Diagnostic Services” Program for Clinical Pathology Laboratories

Registry for genetic tests and molecular diagnostic assays is one step in process to assess the science and clinical utility

Clinical laboratory and pathologists have dozens of questions about the proposed draft local coverage determinations (LCDs) that Medicare carrier Palmetto GBA issued on September 28. The draft LCDs represent Palmetto GBA’s efforts to identify the growing number of laboratory-developed molecular diagnostic assays and genetic tests.

In an exclusive interview with Dark Daily, Palmetto Medical Director Elaine Jeter, M.D., and Palmetto Vice President Mike Barlow explained the need for the new LCDs and offered insight into the process Palmetto GBA is developing to create a molecular test registry and a coverage determination and reimbursement process. This is an important development for the clinical laboratory industry. (more…)

Palmetto, Medicare’s Biggest Carrier, Proposes to End Code Stacking for Molecular Clinical Laboratory Tests

Palmetto wants to implement two proposed local coverage determinations (LCDs) on February 27, 2012

Medicare’s biggest local carrier is ready to tackle the problems created when clinical pathology laboratories use code stacks to submit claims for genetic tests  and molecular diagnostics assays. Medical laboratories in eight states served by this Medicare carrier are worried about its two draft proposals that could cut off reimbursement for large numbers of molecular diagnostic tests (MDTs) and laboratory-developed tests (LDTs), starting February 27, 2012.

The Medicare carrier is Palmetto GBA, of Columbia, South Carolina. On September 23, it shook up the clinical laboratory industry and pathology profession nationwide when it announced, in a “draft proposal” for a local coverage determination (LCD), that it would not allow labs to submit claims for most MDTs. As noted above, the proposed effective date is February 27, 2012.
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