Theresa,
I hope this finds you well. I am copying Dr. Raval given the strategic significance of the NCD pathway analysis to GenomeDx Therapeutics' broader commercialization planning for OncoPrecise GXP-47.
Attached please find our NCD Feasibility Assessment Memorandum (dated today), prepared by Joel Strauss and me, analyzing the feasibility and projected timeline for pursuing a national coverage determination through CMS for OncoPrecise GXP-47. This deliverable was contemplated in our original engagement scope and is intended to complement the LCD/MolDx strategy work previously delivered — specifically, the Revised LCD/MolDx Strategy Memorandum delivered on April 22 and the Draft MolDx Technical Assessment Dossier (Version 1.0) delivered on April 30.
I want to highlight several key conclusions from the memorandum:
1. **NCD Timeline Estimate.** Based on our analysis of CMS's historical NCD processing timelines and the current regulatory environment for molecular diagnostic tests, we estimate an NCD timeline of approximately 18 to 24 months from the date of LCD issuance by Cascade Fiscal Intermediaries. This means that even under the most optimistic scenario — assuming LCD issuance occurs in late 2025 or early 2026 following the revised CLARITY-LUNG final data readout (currently projected for Q2 2025) — national coverage would not be achieved until well into 2027 at the earliest.
2. **Coverage with Evidence Development (CED).** The memorandum analyzes CMS's CED framework as a potential pathway that could allow Medicare coverage while additional clinical evidence is being developed. This pathway is potentially relevant given the CLARITY-LUNG interim results, where positive predictive value came in at 0.68 versus the pre-specified target of ≥ 0.75 and negative predictive value at 0.71 versus the target of ≥ 0.80. However, CED carries its own complexities — including the requirement for an approved study protocol and CMS oversight of data collection — and the memorandum assesses in detail the practical feasibility of this pathway for a laboratory-developed test like OncoPrecise GXP-47. We discuss the pros and cons at length, and I would welcome the opportunity to walk through that analysis with you and Dr. Raval.
3. **Traditional NCD Pathway.** We also evaluate the traditional NCD pathway through a formal request to CMS's Coverage and Analysis Group. This pathway requires a more robust evidentiary base than the current CLARITY-LUNG data supports and would benefit considerably from final trial results demonstrating clinical validity and utility at or above the pre-specified performance thresholds.
4. **Recommendation — LCD First.** Our primary recommendation is to pursue the LCD through Cascade Fiscal Intermediaries — with technical assessment through Ridgeline Administrative Services under the MolDx program — as the first-priority coverage pathway, and to defer initiation of a formal NCD request until after an LCD is in place and GDT has accumulated real-world utilization data and additional clinical evidence. This sequencing is consistent with precedent in the molecular diagnostics space and, importantly, avoids the risk of a premature national-level non-coverage determination, which could be significantly more difficult to reverse than a MAC-level decision. The memorandum addresses whether parallel LCD and NCD tracks would be advisable and concludes that they would not be at this stage.
A few additional notes for context. First, the memorandum's analysis should be read in conjunction with the Clinical Evidence Gap Analysis (delivered April 15) and the Revised LCD/MolDx Strategy Memorandum (delivered April 22), which recommended deferring the LCD filing until final CLARITY-LUNG data is available. Second, the NCD analysis has implications for the revenue projections previously modeled. As you will recall, the projected Year 1 Medicare revenue of approximately $20.3 million at a target reimbursement rate of $3,850 per test assumed LCD-based coverage in a single jurisdiction; national coverage via NCD would substantially expand the addressable Medicare population but is, as the memorandum makes clear, a longer-horizon event. I would suggest coordinating with Kevin and GDT's financial advisor as they update forward models to reflect this timeline. Finally, our Reimbursement Rate Analysis Memorandum — covering crosswalk and gapfill pricing — is being finalized and will be delivered to you shortly.
I would be happy to schedule a call with you, Kevin, and Dr. Raval to walk through the memorandum's conclusions in detail and discuss how the NCD pathway fits into GDT's overall coverage strategy and commercialization timeline. I am aware that the board is continuing to evaluate the path forward for OncoPrecise GXP-47 in light of the CLARITY-LUNG interim data, and we remain fully available to support whatever direction the board determines is appropriate.
Please let me know what times work well for you next week, and we will coordinate from our end.
Best regards,
Miriam Calloway Partner, Healthcare & Life Sciences Practice Calderwood & Harkness LLP 1700 K Street NW, Suite 900 Washington, DC 20006 (202) 555-4183 mcalloway@calderwoodharkness.com