FDA Pushes Forward with Plans to Regulate Laboratory-Developed Tests, in a Move that Will Impact Many Clinical Laboratory Companies and Pathology Groups

Sep 3, 2014 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology

It was national news when the FDA sent notice to Congress on July 31 that it planned to issue draft guidance on regulation of LDTs After sitting in a state of suspended animation for several years, the Food & Drug Administration’s (FDA) plans to regulate laboratory-developed tests are now front and center. On July 31, the FDA served the required 60-day legal notice to Congress that it was ready to move forward to issue rules for regulation of LDTs. If the federal agency wanted to get the...

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

Apr 22, 2013 | Coding, Billing, and Collections, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Managed Care Contracts & Payer Reimbursement

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...
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