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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Exact Sciences Sues Humana Over Cologuard Coverage in Spat over How Insurer Reimburses for This Clinical Laboratory Test

Filing a complaint with the Louisville division of the District Court for the Western District of Kentucky, Exact Sciences seeks payment from Humana for at least 4,664 Cologuard tests as well as coverage for the procedure in the commercial plans offered in mandate states

Citing more than $800,000 in unpaid service fees and damages, the Exact v Humana lawsuit is the latest example of the on-going struggle between health insurers and clinical laboratories offering proprietary and patent-protected lab procedures.

Exact Sciences Corp. (NASDAQ: EXAS), and Exact Sciences Laboratories, LLC (Exact) allege that Humana (NYSE: HUM) has denied 120 claims in Kentucky worth approximately $70,000 as well as 293 additional claims in other states with coverage mandates worth approximately $169,000.

Exact claims that attempts to appeal denied claims resulted in payment for some services but that more than half remain rejected. They also report roughly 350 claims in which Humana underpaid.

They are seeking full payment for all claims made since the start of 2014 in Kentucky, Georgia, Missouri, North Carolina, Texas, Illinois, Nevada, and Oklahoma. (more…)

New Diagnostic Technology Creates Opportunities for Clinical Laboratories to Help Physicians with Faster, More Accurate Diagnoses

Using monoclonal and polyclonal antibodies to detect only human blood in stool, this technology compares favorably when tested against other methodologies

New diagnostic technologies are literally tumbling out of research laboratories and biotech development companies at an increasing pace. The sheer volume of proprietary medical laboratory tests and new molecular diagnostic assays makes it a challenge for pathologists and clinical laboratory managers to identify which new lab tests have the greatest clinical value—and will also be adequately reimbursed by payers.

Each time a clinical laboratory wants to bring up a new medical laboratory test, it requires substantial effort. The laboratory will expend substantial financial, clinical, and operational resources to acquire the instrumentation, run the studies needed to validate the test, and begin the process of educating physicians about the value of the new test and how to use it in their medical practice. (more…)

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