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MolDX Mike barlow, VP.

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Presentation on theme: "MolDX Mike barlow, VP."— Presentation transcript:

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


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