Blog Posts by Date: Jul 2011


FDA's Draft Companion Diagnostics Guidance Document

  • July 29, 2011

For the In Vitro Companion Diagnostic Devices the main message is to develop the diagnostic and drug contemporaneously to ensure drug approval is not delayed. In summary, the FDA will require a submission (likely a PMA) for the diagnostic product that is specifically associated with a new drug (a companion diagnostic). If the companion diagnostic...

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Is Help on the Way?

  • July 28, 2011

The Perfect Storm: Part II webinar today discussed "Is Help on the Way?" and the answer is no. Meetings at both CMS and the AMA this month confirmed that there are still more unanswered questions than answers. How are tests going to be coded and priced by CMS and private payers moving forward? Do we really have until 1/1/2013 to see the impact...

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Result of CMS' 7/18 Meeting

  • July 25, 2011

Details for the Laboratory Public Meeting on Payment for New Clinical Laboratory Tests for 2012 meeting on July 18th CMS on the new AMA CPT codes for genetic tests on the clinical laboratory fee schedule (CLFS) are posted here: http://www.g2intelligence.com. What does all this mean to you as you try to plan for 2012 and beyond? How can the DOS...

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Public Synopsis to be Posted - Stay Tuned

  • July 22, 2011

The AMA/CPT meeting on July 20th discussed the next steps in establishing a process for the construction of a coding mechanism(s) for In Vitro Diagnostic Multivariate Assays (IVDMIA). A public synopsis of the meeting will be published, but it was a valuable opportunity to delve into the AMA proposed category 4 as well as discuss any modifications...

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World's Largest Food Company Spends $567 Million to Buy into Pathology Laboratory Testing and Pharmaceuticals

  • July 15, 2011

As reported this week from the Dark Report, "World's Largest Food Company Spends $567 Million to Buy into Pathology Laboratory Testing and Pharmaceuticals, Nestle says its Prometheus Laboratory acquisition will help it develop products for patients with metabolic conditions and to promote brain health." The injection of investment by large...

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AMA Document on New Category IV CPT Code

  • July 11, 2011

This week, AMA circulated a document proposing a new Category IV CPT Code for "in vitro diagnostic multivariate index assays" (IVDMIA). This comes after the IVDMIA Workgroup was asked to review procedural coding and propose a CPT code solution. The minimum requirements for the granting of a Category IV code are: FDA approval, if required, for...

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CMS July 18th Public Meeting and AMA July 20th Meeting

  • July 11, 2011

Dark Daily reported this week on the CMS public meeting in Baltimore on July 18, 2011 that will discuss reimbursement for pathology groups and clinical laboratories for genetic tests and molecular diagnostic assays and rightfully points out that the stakes for some medical laboratory testing companies are substantial. XIFIN is hosting a webinar...

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