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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Foundation Medicine Striving to Use Next-Generation Gene Sequencing to Enrich Diagnostic Value Offered to Physicians by Clinical Laboratories

Pathologists will want to understand how this innovative company is doing multi-gene analysis of patient tumors that includes information about therapeutics and clinical trials

CAMBRIDGE, MASSACHUSETTS—Next-generation gene sequencing is already changing how cancer is diagnosed and treated for a growing number of patients. Because it moves healthcare closer toward personalized medicine, this development has major implications for anatomic pathology groups and clinical laboratories.

One company in the forefront of personalized medicine is Foundation Medicine, based here in the Boston’s Route 128 biotech corridor. Last week, your Dark Daily Editor, Robert L. Michel, met with the executive team and toured the company’s CLIA-licensed medical laboratory to learn more about this company’s unique approach to clinical diagnostics. (more…)

This Week in Houston, Clinical Laboratory Industry’s Largest Trade Show Provided a Look at New Diagnostic Technologies

Many IVD vendors are cautiously optimistic about the “state of the medical lab industry,” but recognize that declining reimbursement for lab tests is now harming many lab organizations

DATELINE: Houston, Texas—Once again, the American Association of Clinical Chemistry (AACC) and the American Society for Clinical Laboratory Science (ASCLS) attracted a large crowd for their joint annual meeting. And, as is true every year, the activity on the exhibit floor provides valuable insights about the state of the clinical laboratory.

Your Dark Daily editorial team was here all week and had conversations with many executives from in vitro diagnostic  (IVD) manufacturers, laboratory informatics vendors, and specialty test companies.

Nation’s Largest Trade Show for Medical Laboratory Vendors (more…)

Community Clinical Lab Companies Hard Hit by Medicare Lab Test Fee Cuts and Owners Fear Negative Financial Consequences of Coming Price Cuts

Smaller community laboratories serve many of the nation’s nursing homes and long-term care facilities, and ongoing medical lab fee cuts are having major negative consequences

DATELINE: LAS VEGAS, NEVADA—Last week, the National Independent Laboratory Association (NILA), in conjunction with the Association of American Bioanalysts (AAB), conducted its annual conference here. It was a useful snapshot on the state of health for independent community lab companies, particularly given the different reimbursement environment for clinical laboratory testing.

NILA’s members are primarily community clinical laboratories. They generate revenue anywhere from $1 million per year to around $100 million per year. It is believed that there are between 150 and 200 of these types of lab companies across the United States. Further, within the towns and cities they serve, these are often the only medical laboratory organizations that fill important testing niches that were abandoned years ago by the national public lab companies. (more…)

Capitol Hill Hears Message from Independent Clinical Laboratory Owners: Additional Medicare Cuts in 2013 Can Be Financially Devastating

Nation’s smaller independent medical laboratories and pathology groups provide clinical lab testing services in many under-served communities

Nov. 21, 2012, WASHINGTON, DC—Last Thursday, owners of independent clinical laboratory companies fanned out across Capitol Hill to meet with their respective Senators and Representatives. Probably the number one concern of these lab owners was further cuts to the Medicare Part B Clinical Laboratory Test Fee Schedule.

Congress is preparing to tackle a host of spending issues, not the least which is the Medicare Sustainable Growth Rate sustainable growth rates(SGR). Earlier this year, in February, Congress raided Medicare Part B Clinical Laboratory Test Fees by $2.7 billion over 10 years to provide a source of funding to temporarily fix SGR. (See Dark Daily, “In Fixing Physician Medicare Pay, Congress Enacts Yet Another Cut in Clinical Laboratory Test Fee Schedule,” February 20, 2012.) (more…)

Owners of Regional Independent Clinical Pathology Laboratory Companies Gather in Washington DC with Plans to Visit Senators and Representatives

Organized by the National Association of Independent Laboratories, this effort attempts to educate lawmakers about the negative impact of cuts to Medicare Part B Clinical Laboratory Test fees

November 16, WASHINGTON, DC—This week, an intrepid group of clinical laboratory owners gathered in the nation’s capital specifically to visit their Senators and Representatives. The goal was to educate these elected officials about the tenuous financial condition of independent medical laboratory companies.

In particular, ongoing budget cuts to the Medicare Part B Clinical Laboratory Test Fee Schedule are undermining the ability of medical laboratories to deliver top-flight lab test services. This is particularly true for smaller independent clinical laboratories, particularly these located in communities not well-served by national lab companies. (more…)

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