1. MolDX
Mike barlow, VP

2. MolDX Program Update One Year Later – Program Hitting Its Stride
3,200 assays are currently registered
Key Logistics of registration and claims processing now fully in place
Tech Assessments – dossier submissions are improving
9/20/2018
Palmetto GBA, LLC

3. MolDX Next Steps Expand program to Part A services in J1
Add J11 to the program
Nationalization under discussion with CMS
Active discussions with other Payors to leverage to the program
9/20/2018
Palmetto GBA, LLC

4. Lab Update
Elaine Jeter, MD J1 MolDx

5. Agenda Medicare Benefit Medicare Statutory Exclusion
Lab Test Utilization
MPFS / CLFS Final Rule
FDA Approval/Clearance Important
Hgb A1c
CED
9/20/2018
Palmetto GBA, LLC

6. Medicare Lab Test Benefit
Covered - Dx in symptomatic patient
Non-covered:
Risk assessment of asymptomatic family member
Carrier testing
Recurrence risk calculation
Post-mortem dx
9/20/2018
Palmetto GBA, LLC

7. Medicare Statutory Exclusions
Screening – absent sg/sx of disease
Risk assessment – absent sg/sx of disease
Confirmatory diagnosis – when dx is known
QC/QA
Service is not actionable
Investigational & not part of clinical trial
9/20/2018
Palmetto GBA, LLC

8. Laboratory Test Utilization
----- > Is the Responsibility of Lab
Marketing
Test Catalog
Requisition
How test is ordered
What additional info needed
ICD-9 / ICD-10 codes specific to assay
9/20/2018
Palmetto GBA, LLC

9. MTHFR Methylenetetrahydrofolate reductase Indications
Mutation associated w/ hyperhomocysteinemia
Indications
Dx – Hypercoagulable patient – covered
CV risk assessment – non-covered
9/20/2018
Palmetto GBA, LLC

10. ApoE Identifies alleles of ApoE gene Increased susceptibility to:
Alzheimer’s disease – non-covered
CV disease – non-covered
Test results are NOT actionable
9/20/2018
Palmetto GBA, LLC

11. MPFS Final Rule
Calls for statutorily required 26.5% reduction in PFS – ’97 BBA SGR
Congress has overridden since ’03
Obama – committed to fixing the SGR

12. MPFS Final Rule All molecular codes in CLFS
Do not generally require physician interpret
Interpret, when R&N – G0452
Requested by attending physician
Written report in patient’s medical record
Require medical judgement
RVU = 0.37; same as
9/20/2018
Palmetto GBA, LLC

13. Pathology Codes Payment
TC – RVU review
RVUs changes - 52% reduction
TC – from 2.05 to .99
Global – from 3.11 to 2.07
Similar reductions for 88300, & 88304
Comments requested

14. Saturation Biopsy Palmetto GBA article – per NCCI manual
G0416 – saturation bx, specimens
Does not address how to bill for <10 saturation biopsies
Comments to CMS
9/20/2018
Palmetto GBA, LLC

15. “TC Grandfather”
Multiple extensions to payment for Independent Labs for Path TC for IP/OP
CMS confirmed that ILs may not bill M’care for pathology TC after June 30, 2012

16. CLFS Final Rule How molecular codes priced? What happens to MAAAs?
Gap-fill – CR pending
What happens to MAAAs?
9 specific codes - Status “I”
Leaves possibility of coverage open in future
Removed “calculated or algorithmically derived” language from preliminary determination
9/20/2018
Palmetto GBA, LLC

17. Reimbursement Examples
Kras - 27 labs – 25 code stacks
Reimbursement - $172 - $860
EGFR –25 labs – 23 code stacks
Reimbursement – $620 - $1550 w/o $850 - $1900 w/ 88381
9/20/2018
Palmetto GBA, LLC

18. Reimbursement Examples
Braf
29 labs – 21 code stacks
FDA approved assay – 3 labs
26 LDTs – most add micro-dissection
Reimbursement - $85 - $513
9/20/2018
Palmetto GBA, LLC

19. Braf Reimbursement
9/20/2018
Palmetto GBA, LLC

20. Why FDA Approval / Clearance?
Scientific evidence scrutiny
Subject to good manufacturing practices
Adverse event reporting
9/20/2018
Palmetto GBA, LLC

21. LDT Similar to Compounded Drug
Absent external review of validation evidence
Unique selection of assay inclusion/exclusion parameters
Non-standard assay methodology
No guarantee of quality and safety
No reporting of adverse events
9/20/2018
Palmetto GBA, LLC

22. Hgb A1c LCD Draft LCD End date of comment period: Nov 16th
NCD – 1 q 3 mos
LCD
2 q 3 mos
Uncontrolled diabetes
Hypoglycemic coma
Post surgical hypo-insulinemia
1 q mo – pregnant type 1 diabetic woman
9/20/2018
Palmetto GBA, LLC

23. Coverage w/ Evidence Development
Mechanism for rapid patient assay access
Strong analytical & clinical validity
Potentially significant but unproven clinical utility
Affects serious, prevalent Medicare population
Requires submission of clinical trial
Palmetto GBA will not participate in design or study conduct

24. CED Study Requirements
Purpose – does intervention improve health outcomes
Research protocol discusses how results apply to Medicare population
Realistic completion in 3-4 yrs
Adequate resources to complete study
Governance mechanisms to ensure design, implementation & analysis are protected from conflict of interest

25. CED Requirements Cont’d
Research question & protocol guided by input from key stakeholders
Principal sponsor registered on prior to initial study enrollment
Protocol specifies method & timing of public release of results
Protocol discusses subpops affected by treatment under investigation

26. CED Organizational Requirements
Selection of organization to aid development of CED study:
Expertise in design & implementation of CED study & policy issues
Expertise in methodological standards & convening multi-stakeholder working groups
Expertise in comparative effectiveness studies
Experience with coverage & reimbursement policies

27. Questions? Elaine.jeter@palmettogba.com
9/20/2018
Palmetto GBA, LLC