2006 Accomplishments

The promise of personalized medicine and the cures of the future can not be achieved without early diagnosis and the ability to determine the right therapy for the right patient at the right time.  AdvaMed made a major investment in this area this year, creating a molecular diagnostics and genetics work group to make sure that FDA does not develop a new and more onerous regulatory pathway for these critical products.  We aimed to reform the current antiquated reimbursement system and regulatory playing fields that vary for different diagnostic companies and labs.

AdvaMed secured introduction of The Clinical Laboratory Fee Schedule Improvement Act of 2006 to strengthen the reimbursement process for innovative molecular diagnostic tests.  We also dealt with problems in the Medicare Clinical Laboratory Competitive Bidding Demonstration Project, and halted CMS from implementing proposed “medically unlikely edits” that would have had an extremely damaging effect on clinical lab reimbursement.  

Our members also reached consensus on a broad range of regulatory issues, including on analyte-specific reagents, banked samples, and laboratory-developed tests.  After a long effort to see some relief from FDA’s policy on the use of banked and residual samples, AdvaMed’s work helped lead FDA to issue a guidance document outlining the circumstances under which these samples would be allowed.