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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Three Trends in High-Throughput Gene Sequencing for Pathologists and Clinical Laboratory Managers

Two experts predict that tomorrow’s gene sequencing systems may render large swaths of today’s clinical laboratory obsolete

Gene sequencing is the hot technology in both the biotech and clinical laboratory testing industries. That is because the cost of rapid gene sequencing systems is falling rapidly, even as the speed and accuracy of these latest-generation gene sequencers improves significantly.

It is important that medical laboratories managers and pathologists understand the consequences of this technology development curve. The constantly-improving capabilities of these systems means that rapid gene sequencing and whole human genome sequencing will soon take their place in clinical laboratories and anatomic pathology groups.
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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…)

World’s Largest Food Company Spends $567 Million to Buy into Pathology Laboratory Testing and Pharmaceuticals

Nestlé says its Prometheus Laboratory acquisition will help it develop products for patients with metabolic conditions and to promote brain health

When it comes to the brave new world of genetics in pathology and clinical laboratory testing, such terms as pharmacogenomics, companion diagnostics, and personalized medicine have been coined to describe the intersection of genetic testing and molecular diagnostics with emerging medical practice. Now the world’s largest food company is putting forth a vision of how genetic testing can inform decisions about the patient’s nutrition.

It was last May when the health-science unit of Nestlé SA, (VTX:NESN) the giant foods company in Vevey, Switzerland, announced its purchase of Prometheus Laboratories Inc., of San Diego, California. The price was $567 million.

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CMS to Conduct Public Meeting on Genetic and Molecular Laboratory Test Billing

Medicare officials seeking public comment during the July 18 meeting

Changes in how the Medicare program will reimburse pathology groups and clinical laboratories for genetic tests and molecular diagnostic assays will be one of the important topics at an upcoming meeting in Baltimore on July 18, 2011. The federal Centers for Medicare and Medicaid Services (CMS) will conduct the meeting at its headquarters and is asking for public comment as it develops coverage guidelines and reimbursement levels for the 2012 laboratory test fee schedule.

As many pathologists and medical laboratory managers know, a major effort to revise and update CPT codes for genetic and molecular tests performed by clinical laboratories is moving forward. The goal is to recognize advances in this field of diagnostic testing by updating the CPT codes. Another goal, widely supported by private health insurance plans, is to reduce the use of “code stacking” as the primary coding and claims methodology that must be used for a large number of genetic and molecular medical laboratory tests.

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Threat to Clinical Pathology Laboratories is Payer Pre-Authorization of Genetic Tests

Health insurers want to control the rapid growth in expensive genetic and molecular assays

For many clinical laboratories and pathology groups, genetic tests and molecular diagnostic assays are the fastest-growing part of the test menu. This is true both in the increased volume of specimens for genetic tests and the growing number of such medical laboratory tests that are accepted for clinical use.

This is a bright spot for the nation’s clinical pathology laboratories. That’s because many genetic tests and molecular assays deliver significant clinical value to the physician and his or her patient—while generating ample reimbursement for the medical laboratory that performs these tests.

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