1. Update CCLA 2013 AnnuAL MEETING
Mike Barlow, VP Palmetto GBA

2. What’s New MolDX now effective in JE and J11
Dedicated MolDX website –
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

3. 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

4. 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

5. 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

6. 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

7. 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 –
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

8. 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

9. 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

10. Questions?
11/6/2013
PALMETTO GBA