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MolDX Mike barlow, VP
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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
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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
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Lab Update Elaine Jeter, MD J1 MolDx
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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
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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
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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
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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
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MTHFR Methylenetetrahydrofolate reductase Indications
Mutation associated w/ hyperhomocysteinemia Indications Dx – Hypercoagulable patient – covered CV risk assessment – non-covered 9/20/2018 Palmetto GBA, LLC
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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
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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
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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
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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
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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
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“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
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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
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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
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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
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Braf Reimbursement 9/20/2018 Palmetto GBA, LLC
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Why FDA Approval / Clearance?
Scientific evidence scrutiny Subject to good manufacturing practices Adverse event reporting 9/20/2018 Palmetto GBA, LLC
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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
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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
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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
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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
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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
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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
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Questions? Elaine.jeter@palmettogba.com
9/20/2018 Palmetto GBA, LLC
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