Update CCLA 2013 AnnuAL MEETING Mike Barlow, VP Palmetto GBA

What’s New MolDX now effective in JE and J11 Dedicated MolDX website – www.PalmettoGBA.com/MolDX All program material in one dedicated site Updated MolDX coverage guidelines manual Dedicated listserv registration and messaging Master Edit File being developed for use by MACs to adjudicate claims by Test ID Editing for NPI/Identifier/CPT Applies MolDX determined coverage 11/6/2013 PALMETTO GBA

MolDX J1 to JE – MolDX coding, coverage, and reimbursement – Remain unchanged Molecular Diagnostic Testing LCD MolDX Master Edit File (maintained by Palmetto GBA) fully implemented by Noridian J11 – MDT policy – to CAC Comment period – 7/16/13 to 8/30/13 Notice period – 9/1/13 to 10/17/13 Effective – 10/18/13 11/6/2013 PALMETTO GBA

Updated TA Process Focus Initial Submission and Review on Clinical Utility (CU) Labs will prepare initial CU submission – We will assign to multiple subject matter experts (panel) Written documentation of panel findings to lab If CU is sufficient, Palmetto GBA will request remaining Analytical & Clinical Validation data if not included in original dossier If CU insufficient, Palmetto GBA will provide points to address in re-submission (6 month) 11/6/2013 PALMETTO GBA

The Coverage Paradox Manufactures/Lab Service Providers should not expect, and payers cannot promise, coverage of and appropriate reimbursement for every new test that comes to market Payers cannot expect, and manufacturers and labs cannot promise, the same level of evidence for all tests MolDX mission is to try and make the process a dialogue and as transparent as we can 11/6/2013 PALMETTO GBA

Pre-Submission Review Will be adding a pre- TA submission process Provides opportunity for the Lab +/or Manufacturer to present their data “for discussion” MolDX team will schedule a call to discuss initial review or pose questions that will need to be addressed in the final TA submission 11/6/2013 PALMETTO GBA

Coverage With Evidence Development (CED) Option for tests with strong clinical validity but clinical utility not fully/clearly documented We have defined our approach and the expected study designs to support CED consideration on the MolDX website – www.PalmettoGBA.com/MolDX Palmetto GBA will review submission and study design to determine if an LCD providing CED is supported by the test and study design 11/6/2013 PALMETTO GBA

Test Registration Centralized Test Registration for Identifiers Note AMA-McKesson CPT / Z-identifier collaboration Master Edit File developed for use by MACs to adjudicate claims by Test ID Editing for NPI/Identifier/CPT Applies MolDX determined coverage 11/6/2013 PALMETTO GBA

MolDX – New Tech / New Challenges Technology providing new data Whole Genome Sequencing Complex Informatics New Levels of Specificity Challenge is the technology (and/or its capabilities) is outpacing the clinical value/ utility dynamic Industry needs to bring both along together 11/6/2013 PALMETTO GBA

Questions? 11/6/2013 PALMETTO GBA