TAG:
molecular diagnostic
CMS Cuts BRCA Price by 49% in Response to Competition
IN THE FINAL WEEKS OF 2013, the federal Centers for Medicare & Medicaid Services (CMS) announced that it would reduce the price it pays for the BRCA genetic test by 49%, to $1,438, effective on January 1, 2014. For Myriad Genetics, Inc., this wa…
Lab Companies’ IPOs Go Two-for-Three in November
CEO SUMMARY: This fall, a parade of molecular and genetic test companies moved forward with initial public offerings (IPOs) of their stock. In September, Foundation Medicine raised $106 million from its IPO. Encouraged by this success, three different companies proceeded with IPOs during …
Medicare Price Cuts Drive Labs to Sell or File BK
CEO SUMMARY: Professional investors are smart with their money. Thus, it is no surprise that clinical lab and pathology companies owned by private equity firms are the first to be sold or closed. These investors are acting in response to the cumulative negative financial impact of recent …
September 9, 2013 “Intelligence: Late Breaking Lab News”
bioMérieux is on the move. Last week it announced that it would pay $450 million to purchase privately-held BioFire Diagnostics of Salt Lake City, Utah. BioFire has a solid tech- nology base in molecular diagnostics. It developed and currently markets its FilmArray…
House Bill Introduced to Address Rate-Setting for Molecular Tests
FEW PATHOLOGISTS OR CLINICAL laboratory directors would argue against revising the current Medicare payment policies for molecular and genetic tests. A bill proposed in Congress would do just that. The process now in use by Medicare Administrative Contractors (MACs) is inefficient and opaque, accord…
Medicare Contractor’s Ruling on MolDx Test Causes Lab to Close
CEO SUMMARY: On May 14, Predictive Biosciences learned that its Medicare contractor had determined that one of its three molecular tests for bladder cancer was a screening test. It also never got a determination on its other two molecular tests. Because Medicare is half of the lab’s pay…
Labs Have New Hurdles as Some Payments Start
CEO SUMMARY: Some payments are beginning to flow for claims submitted under the new molecular test CPT codes. But there is a new issue. Medicare contractors, Medicaid programs, and private health insurers are deeming certain molecular tests to be medically unnecessary. Th…
Labs Face Consequences from MolDx Test ‘Mess’
CEO SUMMARY: Non-payment of molecular test claims for the first five months of 2013 is not the only financial disruption for labs that perform these tests. Reports are coming in about how Medicare contractors, Medicaid programs, and private payers are declining to pay claims based on ruli…
Big Lab Industry Stories Reveal Trouble Ahead
CEO SUMMARY: One after another, a series of breaking news stories points to more rough waters ahead for the entire clinical lab industry. Of greatest interest is the ongoing questions about when clinical labs and pathology groups will get paid for the molecular test claims they have submi…
Why One Molecular Diagnostics Company Closed Its Doors
CEO SUMMARY: When executives closed the doors of Pathwork Diagnostics last month, the simple explanation was that reimbursement for its proprietary molecular diagnostic test was inadequate. Indeed, that was part of the story. But other factors played significant roles in impeding…
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Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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