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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Major Biobanking Center Planned for Kannapolis, North Carolina, in Tandem with a Multi-Decade Study of the Role of Genetics in Chronic Disease

Pathologists and clinical laboratory scientists may see this research initiative—dubbed the MURDOCK Study—produce knowledge that results in new diagnostic medical lab tests

Can molecular biomarkers do for a North Carolina town what silicon chips did for California’s Silicon Valley? At least one city in the Tar Heel State hopes that it can develop into a major hub for research, development, and the commercialization of molecular science and next-generation gene sequencing.

The unlikely contender pursuing this goal is the city of Kannapolis. With a population of 43,000 and located about 25 miles northwest of Charlotte, the city fathers of Kannopolis appear to be positioning the community as an up-and-coming global center for biobanking. (more…)

Clinical Pathology Laboratories Still Waiting for Molecular Test Payments, Speakers Report at First Day of Executive War College

For more than a year Medicare contractors have been developing payment rates for the 114 molecular tests and without setting rates, they cannot make payments.

New Orleans, Louisiana, April 30, 2013—Getting paid for molecular test claims submitted under the new molecular CPT codes was a subject of high interest on the opening day of the Executive War College. Most clinical laboratories and pathology groups performing molecular tests nationwide report that they have not been paid for invoices submitted to Medicare contractors since January 1, 2013.

Several sessions were devoted to this important topic. Medicare contractors nationwide have not paid many of the molecular diagnostic test claims submitted since January 1 according to speakers and attendees at the first day of The Dark Report’s 18th Annual Executive War College in New Orleans. (more…)

Forbes Tells the World How Medicare Bollixed Molecular Diagnostic Test Payments, Leaving Nation’s Clinical Laboratories Unpaid for Months

Columnist Steve Gottlieb, M.D., wrote that “This sort of bungling may be without precedent, even for the Medicare agency”

Since the beginning of the year, most Medicare contractors and private health insurers have not paid clinical laboratories and anatomic pathology practices for molecular diagnostic test claims coded to the 114 new molecular test CPT codes.

This unprecedented situation of labs going unpaid for more than three months has created financial turmoil and uncertainty across the medical laboratory profession. In fact, the question must be asked: Did Forbes columnist Scott Gottlieb, M.D., wake up the nation’s Medicare contractors with his column published on March 27? (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.