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Contract analysis / board-presentation-coverage-strategy.pptx
board-presentation-coverage-strategy.pptx
High · 1
Medium · 1
Standard · 0
1. Executive Summary & Engagement Scope
1. Executive Summary & Engagement Scope
2. OncoPrecise GXP-47 — Product & Clinical Overview
2. OncoPrecise GXP-47 — Product & Clinical Overview
3. CLARITY-LUNG Trial — Interim Results & Implications
3. CLARITY-LUNG Trial — Interim Results & Implications
4. Coding Strategy — PLA Code Application
4. Coding Strategy — PLA Code Application
5. Medicare Coverage Pathway — LCD via MolDx Program
5. Medicare Coverage Pathway — LCD via MolDx Program
6. National Coverage Determination (NCD) — Feasibility & Timeline
6. National Coverage Determination (NCD) — Feasibility & Timeline
7. Reimbursement Rate Analysis — Crosswalk & Pricing
7. Reimbursement Rate Analysis — Crosswalk & Pricing
8. Revenue Projections — Medicare & Commercial
8. Revenue Projections — Medicare & Commercial
9. Risk Factors & Key Considerations
9. Risk Factors & Key Considerations
10. Recommended Next Steps & Decision Points
High
⚑ Non-compete / exclusivity restraint
10. Recommended Next Steps & Decision Points [slide 3] Executive Summary & Engagement Scope Calderwood & Harkness engaged February 14, 2024 to develop and execute a comprehensive Medicare coverage and coding strategy for OncoPrecise GXP-47 Scope: (1) Obtain unique PLA code via AMA CPT Editorial Panel; (2) Secure LCD from Cascade Fiscal Intermediaries (Jurisdiction E MAC); (3) Establish Medicare reimbursement rate via
1. Defer LCD filing with CFI and MolDx submission to RAS until final CLARITY-LUNG data is
1. Defer LCD filing with CFI and MolDx submission to RAS until final CLARITY-LUNG data is available (projected Q2 2025)
2. Proceed with PLA code application by June 28, 2024 deadline to preserve AMA September 2
Medium
⚑ Assignment / subcontracting
2. Proceed with PLA code application by June 28, 2024 deadline to preserve AMA September 2024 Panel slot — PLA assignment is independent of coverage determination
3. Complete draft MolDx Technical Assessment Dossier (v1.0) by April 30 for readiness upon
3. Complete draft MolDx Technical Assessment Dossier (v1.0) by April 30 for readiness upon final data availability
4. Commission supplemental evidence strategies (sub-group analyses, retrospective studies)
4. Commission supplemental evidence strategies (sub-group analyses, retrospective studies) — coordinate with Dr. Sundaram and Larkfield Health Economics
5. Engage Whitford & Sable on PCNB covenant interpretation; consider proactive lender dial
5. Engage Whitford & Sable on PCNB covenant interpretation; consider proactive lender dialogue with Pacific Coast National Bank
6. Verdant Life Sciences Capital to revise financial projections reflecting delayed launch
6. Verdant Life Sciences Capital to revise financial projections reflecting delayed launch timeline
7. Calderwood & Harkness deliverables: Clinical Evidence Gap Analysis (Apr 15), Revised LC
7. Calderwood & Harkness deliverables: Clinical Evidence Gap Analysis (Apr 15), Revised LCD/MolDx Strategy Memo (Apr 22), MolDx Dossier v1.0 (Apr 30), NCD Feasibility Assessment (May 10), Reimbursement Rate Analysis (May 14) [slide 15] Appendix A: Engagement Timeline — Key Milestones & Deliverables Feb 14, 2024 — Engagement letter executed; matter opened Feb 28, 2024 — Kickoff meeting (GDT, Calderwood & Harkness, Car