[sheet: Crosswalk Comparator Analysis]

[sheet: Crosswalk Comparator Analysis]
Comparator ID | Code Type | Code Number | Test Name | Manufacturer / Laboratory | Test Description | Gene Panel Size | Specimen Type | Clinical Indication | Algorithm / Score Output | Current Medicare Rate ($/test) | Rate Effective Date | MolDx Coverage Status | LCD / NCD Reference | Comparability Score (1–5) | Comparability Notes
Comp-1 | PLA | 0250U | GeneSight Onco-48 | Elara Genomic Sciences, Inc. | 48-gene NGS expression panel for solid tumor therapy selection | 48 | FFPE tissue | Solid organ neoplasm — oncology | Therapy selection score | $3,742.00 | 2024-01-01 | Covered | LCD (via MolDx / Ridgeline Administrative Services, LLC) | 5 | Closest comparator: similar gene panel size (48 vs. 47), NGS-based, FFPE specimen, proprietary algorithm output; oncology indication
Comp-2 | CPT | 81455 | NGS, solid organ neoplasm, 51 or greater genes | Multiple laboratories (generic CPT code) | Next-generation sequencing, solid organ or hematolymphoid neoplasm, DNA and RNA analysis, 51 or greater genes | 51+ | FFPE tissue | Solid organ neoplasm — broad oncology | No proprietary algorithm; raw variant/expression data | $2,919.00 | 2024-01-01 | Covered (generic code) | National fee schedule | 3 | Lower comparability: generic CPT code without proprietary algorithmic interpretation; broader indication; higher gene count threshold; no composite score output
Comp-3 | PLA | 0239U | TumorMap Pro | Marlowe Asset Management Molecular Diagnostics, Inc. | Multi-gene RNA/DNA expression and mutation panel for tumor profiling with predictive algorithm | 52 | FFPE tissue | Solid organ neoplasm — oncology | Predictive response algorithm score | $4,206.00 | 2024-01-01 | Covered | LCD (via MolDx / Ridgeline Administrative Services, LLC) | 4 | Strong comparator: proprietary algorithm with predictive score; slightly larger panel (52 genes); broader tumor type coverage beyond NSCLC
SUMMARY | Weighted Average of Comparators | $3,622.33 | Minimum: $2,919.00 | Maximum: $4,206.00 | Range: $1,287.00 | Median: $3,742.00 | Average of Comp-1 ($3,742), Comp-2 ($2,919), Comp-3 ($4,206)
[sheet: Premium Justification]
Parameter | Value | Notes
--- CROSSWALK SUMMARY ---
Weighted Average of Comparators | $3,622.33 | Average of Elara 0250U ($3,742), CPT 81455 ($2,919), Marlowe Asset Management 0239U ($4,206)
Median Comparator Rate | $3,742.00 | Median of three comparators
Minimum Comparator Rate | $2,919.00 | CPT 81455 (generic NGS code)
Maximum Comparator Rate | $4,206.00 | Marlowe Asset Management 0239U (TumorMap Pro)
--- TARGET RATE ANALYSIS ---
Proposed Target Rate (OncoPrecise GXP-47) | $3,850.00 | Per crosswalk analysis and premium justification
Premium Over Weighted Average ($) | $227.67 | $3,850.00 - $3,622.33
Premium Over Weighted Average (%) | 6.28% | ($3,850.00 - $3,622.33) / $3,622.33 = 6.28%
Premium Over Median ($) | $108.00 | $3,850.00 - $3,742.00
Premium Over Median (%) | 2.89% | ($3,850.00 - $3,742.00) / $3,742.00
Discount from Maximum ($) | $356.00 | $4,206.00 - $3,850.00
Discount from Maximum (%) | 8.46% | ($4,206.00 - $3,850.00) / $4,206.00
--- PREMIUM JUSTIFICATION FACTORS ---
Factor 1: Proprietary TRI Algorithm | Primary justification | OncoPrecise GXP-47 produces a composite Therapy Response Index (TRI) score (0–100) stratifying patients into High (≥70), Intermediate (40–69), and Low (<40) likelihood of ICI response — unique algorithmic output not replicated by comparators
Factor 2: Disease-Specific Focus (NSCLC) | Moderate justification | Test specifically validated for Stage IIIB/IV NSCLC ICI therapy response prediction; comparators are broader pan-tumor panels
Factor 3: 47-Gene RNA Expression Panel Design | Supporting justification | Optimized 47-gene panel balances comprehensiveness with targeted clinical utility; comparable to Elara's 48-gene and Marlowe Asset Management's 52-gene panels
Factor 4: Clinical Validation (CLARITY-LUNG Trial) | Pending — trial ongoing | Prospective multi-site clinical validation study (NCT05891247); 14 sites; 847 of 1,200 patients enrolled (70.58%); interim PPV = 0.68 (target ≥0.75), NPV = 0.71 (target ≥0.80) — results inconclusive at interim; final readout projected Q2 2025
Factor 5: Analytical Validation Published | Supporting justification | Published in Journal of Molecular Oncology Diagnostics, Vol. 18, Issue 4, pp. 412–429, December 2022; completed December 14, 2022
Factor 6: Single-Site CLIA/CAP Laboratory | Neutral | Performed exclusively at GDT's CLIA-certified (05D2187432), CAP-accredited (9074821) reference laboratory in San Diego, CA; NPI 1902847365
--- RATE POSITIONING SUMMARY ---
Position vs. Comparator Range | Mid-to-upper range | $3,850 sits between median ($3,742) and maximum ($4,206); closer to median
Recommended Rate for LCD Application | $3,850.00/test | Supportable crosswalk rate with 6.28% premium over weighted average justified by proprietary TRI algorithm
Alternative Gapfill Rate (see Gapfill Pricing tab) | See Tab 4 | Gapfill methodology yields alternative rate estimate
[sheet: Revenue Projection Sensitivity]
Parameter / Scenario | Year 1 | Year 2 | Year 3 | Notes
=== A. BASE CASE ASSUMPTIONS === | Per GDT/Verdant Life Sciences Capital financial models
Total Projected Test Volume | 8,500 | 15,200 | 22,000 | At full commercial launch; modeled by Verdant Life Sciences Capital, LLC (Christine Lau, Managing Director)
Medicare Payer Mix (%) | 62% | 62% | 62% | Percentage of total volume reimbursed by Medicare
Commercial Payer Mix (%) | 38% | 38% | 38% | Percentage of total volume reimbursed by commercial payers
Medicare Test Volume | 5,270 | 9,424 | 13,640 | = Total Volume × 62%
Commercial Test Volume | 3,230 | 5,776 | 8,360 | = Total Volume × 38%
Target Medicare Reimbursement Rate | $3,850.00 | $3,850.00 | $3,850.00 | Per crosswalk analysis (see Crosswalk Comparator Analysis tab)
Average Commercial Reimbursement Rate | $4,400.00 | $4,400.00 | $4,400.00 | Blended commercial payer rate assumption
=== B. BASE CASE REVENUE PROJECTIONS ===
Medicare Revenue | $20,289,500 | $36,282,400 | $52,514,000 | = Medicare Volume × $3,850
Commercial Revenue | $14,212,000 | $25,414,400 | $36,784,000 | = Commercial Volume × $4,400
Total Revenue | $34,502,500 | $61,696,800 | $89,298,000 | = Medicare Revenue + Commercial Revenue
Medicare Revenue as % of Total | 58.8% | 58.8% | 58.8% | = Medicare Revenue / Total Revenue
=== C. RATE SENSITIVITY — MEDICARE REIMBURSEMENT RATE SCENARIOS ===
Scenario C1: Rate = Weighted Avg ($3,622.33) | $19,091,679 | $34,138,373 | $49,408,541 | = Medicare Volume × $3,622.33
Scenario C1: Total Revenue | $33,303,679 | $59,552,773 | $86,192,541 | = C1 Medicare Revenue + Commercial Revenue
Scenario C1: Revenue Impact vs. Base | -$1,198,821 | -$2,144,027 | -$3,105,459 | Revenue reduction from using weighted avg rate instead of $3,850
Scenario C2: Rate = Min Comp ($2,919) | $15,383,130 | $27,509,256 | $39,823,160 | = Medicare Volume × $2,919
Scenario C2: Total Revenue | $29,595,130 | $52,923,656 | $76,607,160 | = C2 Medicare Revenue + Commercial Revenue
Scenario C2: Revenue Impact vs. Base | -$4,907,370 | -$8,773,144 | -$12,690,840 | Downside scenario at lowest comparator rate
Scenario C3: Rate = Max Comp ($4,206) | $22,165,020 | $39,636,144 | $57,369,840 | = Medicare Volume × $4,206
Scenario C3: Total Revenue | $36,377,020 | $65,050,544 | $94,153,840 | = C3 Medicare Revenue + Commercial Revenue
Scenario C3: Revenue Impact vs. Base | +$1,874,520 | +$3,353,744 | +$4,855,840 | Upside scenario at highest comparator rate
Scenario C4: Rate = Median Comp ($3,742) | $19,721,540 | $35,264,608 | $51,037,480 | = Medicare Volume × $3,742
Scenario C4: Total Revenue | $33,933,540 | $60,679,008 | $87,821,480 | = C4 Medicare Revenue + Commercial Revenue
=== D. VOLUME SENSITIVITY SCENARIOS ===
Scenario D1: Volume -20% | 6,800 | 12,160 | 17,600 | Conservative volume scenario
Scenario D1: Medicare Volume | 4,216 | 7,539 | 10,912 | = Volume × 62%
Scenario D1: Commercial Volume | 2,584 | 4,621 | 6,688 | = Volume × 38%
Scenario D1: Total Revenue | $27,602,000 | $49,357,440 | $71,438,400 | = (4,216 × $3,850) + (2,584 × $4,400)
Scenario D1: Revenue Impact vs. Base | -$6,900,500 | -$12,339,360 | -$17,859,600 | Revenue reduction from -20% volume
Scenario D2: Volume +20% | 10,200 | 18,240 | 26,400 | Optimistic volume scenario
Scenario D2: Medicare Volume | 6,324 | 11,309 | 16,368 | = Volume × 62%
Scenario D2: Commercial Volume | 3,876 | 6,931 | 10,032 | = Volume × 38%
Scenario D2: Total Revenue | $41,403,000 | $74,036,160 | $107,157,600 | = (6,324 × $3,850) + (3,876 × $4,400)
Scenario D2: Revenue Impact vs. Base | +$6,900,500 | +$12,339,360 | +$17,859,600 | Revenue increase from +20% volume
=== E. PAYER MIX SENSITIVITY ===
Scenario E1: Medicare Mix 55% / Commercial 45% | Shift toward commercial payers
Scenario E1: Medicare Volume | 4,675 | 8,360 | 12,100 | = Total Volume × 55%
Scenario E1: Commercial Volume | 3,825 | 6,840 | 9,900 | = Total Volume × 45%
Scenario E1: Total Revenue | $34,848,750 | $62,336,000 | $90,245,000 | = (4,675 × $3,850) + (3,825 × $4,400)
Scenario E1: Revenue Impact vs. Base | +$346,250 | +$639,200 | +$947,000 | Higher commercial mix increases total revenue due to higher commercial rate
Scenario E2: Medicare Mix 70% / Commercial 30% | Higher Medicare dependence
Scenario E2: Medicare Volume | 5,950 | 10,640 | 15,400 | = Total Volume × 70%
Scenario E2: Commercial Volume | 2,550 | 4,560 | 6,600 | = Total Volume × 30%
Scenario E2: Total Revenue | $34,127,500 | $61,028,000 | $88,330,000 | = (5,950 × $3,850) + (2,550 × $4,400)
Scenario E2: Revenue Impact vs. Base | -$375,000 | -$668,800 | -$968,000 | Higher Medicare mix reduces total revenue due to lower Medicare rate vs. commercial
=== F. CONTEXT: GDT FINANCIAL POSITION ===
GDT FY2023 Revenue (GXP-12 only) | $6,200,000 | Current revenue base from OncoPrecise GXP-12 (LCD L38472, eff. 08/15/2021)
GDT Annual Burn Rate | ~$34,000,000 | Annual operating expenses
PCNB Revolving Facility — Total | $15,000,000 | Pacific Coast National Bank; Ref. PCNB-GDT-RF-2023-0922
PCNB Revolving Facility — Outstanding Draw (May 2024) | $9,200,000 | Interest: SOFR + 3.75%; Maturity: 09/22/2026
PCNB Milestone Covenant Deadline | 12/31/2024 | Section 7.14: Obtain Medicare coverage determination for at least one LDT; 90-day cure to 03/31/2025
Total GDT Funding (Series A–C) | ~$187,000,000 | Series C ($78M) led by Pinnacle Health Ventures, L.P., closed 03/28/2022; PHV holds 41.3% fully diluted equity
CLARITY-LUNG Trial Budget / Spend | $28,500,000 / $19,100,000 | 67.02% spent through May 2024; 847 of 1,200 enrolled (70.58%); final readout revised to Q2 2025
[sheet: Gapfill Pricing Scenario]
Component / Parameter | Value | Source / Notes
=== GAPFILL METHODOLOGY OVERVIEW === | Alternative to crosswalk; applied when no sufficiently similar existing test code identified; rate set based on charges, resources, and payment for similar tests during initial gapfill period
=== DIRECT COST COMPONENTS (PER TEST) === | Based on GDT laboratory operational data
Reagent & Consumable Costs | $485.00 | NGS reagents, RNA extraction kits, FFPE processing materials for 47-gene panel
Labor — Specimen Processing & Wet Lab | $210.00 | Histotechnologist, lab technician time for FFPE sectioning, RNA extraction, library prep, sequencing run
Labor — Bioinformatics & TRI Score Computation | $175.00 | Bioinformatician time for data processing, TRI algorithm application, QC review
Labor — Pathologist Review & Reporting | $295.00 | Board-certified molecular pathologist sign-out and clinical report generation
Equipment Depreciation (per test allocation) | $82.00 | NGS sequencer, automated extraction systems, ancillary equipment
Quality Control & Proficiency Testing (per test allocation) | $38.00 | CLIA/CAP compliance, proficiency testing, internal QC controls
Total Direct Costs Per Test | $1,285.00 | Sum of above direct cost components: $485 + $210 + $175 + $295 + $82 + $38 = $1,285
=== INDIRECT COST COMPONENTS (PER TEST) ===
Facility Overhead (rent, utilities, maintenance) | $145.00 | San Diego reference laboratory at 4720 Torrey Pines Road, Suite 300
IT Infrastructure & Data Security | $62.00 | HIPAA-compliant data systems, cloud computing for bioinformatics pipeline
Regulatory Compliance & Accreditation | $48.00 | CLIA (05D2187432), CAP (9074821) ongoing compliance costs
Administrative & General Overhead | $95.00 | Billing, customer service, specimen logistics, general administration
Intellectual Property Amortization | $55.00 | Allocation of 14 issued U.S. patents and 7 pending applications related to OncoPrecise platform
Total Indirect Costs Per Test | $405.00 | Sum of above indirect cost components: $145 + $62 + $48 + $95 + $55 = $405
=== TOTAL COST & MARGIN ANALYSIS ===
Total Cost Per Test (Direct + Indirect) | $1,690.00 | = $1,285 + $405
Industry Standard Margin (diagnostics) | 20%–30% | Range observed in molecular diagnostics gapfill pricing
Gapfill Rate Estimate (at 20% margin) | $2,028.00 | = $1,690 × 1.20
Gapfill Rate Estimate (at 25% margin) | $2,112.50 | = $1,690 × 1.25
Gapfill Rate Estimate (at 30% margin) | $2,197.00 | = $1,690 × 1.30
=== COMPARISON TO CROSSWALK RATE ===
Proposed Crosswalk Rate | $3,850.00 | Per Premium Justification tab
Gapfill Estimate (25% margin) | $2,112.50
Crosswalk Premium Over Gapfill ($) | $1,737.50 | = $3,850.00 - $2,112.50
Crosswalk Premium Over Gapfill (%) | 82.2% | = ($3,850.00 - $2,112.50) / $2,112.50
=== RECOMMENDATION ===
Preferred Pricing Methodology | Crosswalk | Crosswalk methodology strongly preferred; gapfill methodology significantly undervalues the proprietary TRI algorithm, clinical evidence investment (CLARITY-LUNG: $28.5M budget), and unique clinical utility in NSCLC ICI therapy selection
Risk if MAC Applies Gapfill | High revenue impact | Year 1 Medicare revenue at gapfill rate ($2,112.50): 5,270 × $2,112.50 = $11,132,875 vs. base case $20,290,500; reduction of $9,157,625 (45.1%)
Mitigation Strategy | Strengthen crosswalk justification | Emphasize proprietary algorithm, head-to-head comparability to PLA-coded tests (Elara 0250U, Marlowe Asset Management 0239U), and disease-specific clinical validation; submit robust supporting documentation with LCD/MolDx dossier to Cascade Fiscal Intermediaries (Dr. William Hargrove, Sandra Phu) and Ridgeline Administrative Services (Dr. Catherine Embry)
[sheet: Document Info]
Field | Value
Document Title | Reimbursement Rate Crosswalk Model — OncoPrecise GXP-47
Prepared By | Sean Morrissey, Senior Associate, and Christopher Aiken, Associate — Calderwood & Harkness LLP, Healthcare & Life Sciences
Reviewed By | Miriam Calloway, Partner — Calderwood & Harkness LLP
Matter Number | 1043-00002
Client Number | 47832
Client | Genome Dx Therapeutics Inc.
Client Contact — Reimbursement | Kevin Driscoll, VP of Market Access & Reimbursement
Client Contact — Finance | Raymond Ota, Chief Financial Officer
Date Prepared | May 14, 2024
Supporting Memorandum | Reimbursement Rate Analysis Memorandum — Crosswalk/Gapfill Pricing for OncoPrecise GXP-47 (dated May 14, 2024)
Financial Model Source | Revenue projection assumptions sourced from Verdant Life Sciences Capital, LLC (Christine Lau, Managing Director) and GDT internal models; reviewed by Calderwood & Harkness for reimbursement rate assumptions only
HEOR Data Source | Health economics inputs informed by Larkfield Health Economics, LLC (Dr. Nathan Ostroff, Principal Consultant) work product
Coding Consultant | Carraway Regulatory Advisors, Inc. (Janet Carraway, CPC, CCS-P) — crosswalk comparator identification and PLA/CPT coding mechanics
Target Product | OncoPrecise GXP-47 — 47-gene RNA expression panel, FFPE tissue, Therapy Response Index (TRI) score, Stage IIIB/IV NSCLC
Proposed PLA Code | 0XXXU (placeholder — application targeted for AMA CPT Editorial Panel September 2024 meeting; submission deadline June 28, 2024; not submitted due to matter termination June 3, 2024)
Target LCD Filing | August 2024 with Cascade Fiscal Intermediaries, LLC (Jurisdiction E, California) via MolDx program administered by Ridgeline Administrative Services, LLC — deferred per revised strategy
Status | Matter terminated June 3, 2024; model reflects pre-termination analysis; all projections are contingent on successful clinical validation, LCD issuance, and commercial launch
Confidentiality | PRIVILEGED AND CONFIDENTIAL — Attorney Work Product — Prepared in anticipation of regulatory proceedings