Janet,
I hope you had a good weekend. I'm writing in connection with our ongoing OncoPrecise GXP-47 Medicare coverage and coding engagement for Genome Dx Therapeutics Inc. (Matter No. 1043-00002). Attached for your review and comment are (1) the draft PLA code application for OncoPrecise GXP-47 and (2) a redline markup of the proposed PLA code descriptor. We would appreciate your input on both documents before we deliver the draft package to the GDT client team — Theresa Nakamura and Kevin Driscoll — on Friday, March 22, 2024.
As you'll recall, this draft builds on the coding pathway analysis set forth in our Coding Strategy Memorandum delivered on March 11, which recommended pursuing a Proprietary Laboratory Analyses (PLA) code for GXP-47 rather than billing under an existing CPT code such as 81455. We believe a dedicated PLA code is the stronger pathway for the reasons discussed in that memorandum, and the attached application is our first full draft toward that end.
**Summary of Draft Application**
The draft application is targeted for submission to the AMA CPT Editorial Panel in connection with its September 2024 meeting, for which the submission deadline is June 28, 2024. The key elements of the application are as follows:
*Proposed PLA Code Descriptor:* "OncoPrecise GXP-47 (Genome Dx Therapeutics Inc.), genomic profiling, non-small-cell lung cancer, 47-gene RNA expression panel, formalin-fixed paraffin-embedded tissue, algorithm-derived Therapy Response Index (TRI) score."
*Test Methodology:* The test utilizes a 47-gene RNA expression panel, with RNA extracted from FFPE NSCLC tumor tissue. The assay produces a composite Therapy Response Index (TRI) score ranging from 0 to 100, which stratifies patients into three categories: High Likelihood of Response (TRI ≥ 70), Intermediate (TRI 40–69), and Low Likelihood of Response (TRI < 40) for immune checkpoint inhibitor (ICI) therapy in Stage IIIB/IV NSCLC.
*Clinical Indications:* The test is intended to guide oncologist decision-making on whether to initiate first-line ICI therapy (e.g., pembrolizumab, nivolumab, atezolizumab) versus platinum-based chemotherapy in patients with Stage IIIB/IV NSCLC.
*Specimen Type:* Formalin-fixed, paraffin-embedded (FFPE) tumor tissue.
*Laboratory Information:* OncoPrecise GXP-47 is performed exclusively as a laboratory-developed test (LDT) at GDT's single CLIA-certified, CAP-accredited reference laboratory in San Diego, California (CLIA No. 05D2187432; CAP No. 9074821; NPI 1902847365), located at 4720 Torrey Pines Road, Suite 300, San Diego, CA 92130.
*Supporting Documentation:* The application references the analytical validation study published in the *Journal of Molecular Oncology Diagnostics* (Vol. 18, Issue 4, pp. 412–429, December 2022). It also references clinical validation data from the CLARITY-LUNG trial (NCT05891247), which is currently ongoing with enrollment in progress.
**Areas Where We Would Especially Value Your Input**
Given your deep expertise in the PLA submission process, there are several specific areas where your review would be particularly helpful:
1. **Code Descriptor Language.** Could you please review the proposed PLA code descriptor (see the attached redline) for compliance with AMA formatting conventions and editorial standards? One point I want to flag specifically: the descriptor needs to clearly distinguish OncoPrecise GXP-47 from GDT's existing commercial product, OncoPrecise GXP-12, which is a 12-gene panel for early-stage breast cancer prognosis. GXP-12 already has an existing LCD (LCD L38472, effective August 15, 2021) and is billed under a separate code. We want to ensure there is no ambiguity or potential for confusion between the two products in the descriptor language.
2. **AMA Submission Formatting and Procedural Requirements.** I would appreciate your guidance on any specific formatting, documentation, or procedural requirements for PLA code submissions to the AMA CPT Editorial Panel that our draft may not yet fully address. I know you have successfully shepherded multiple PLA applications through this process, and your expertise on the mechanics is critical to making sure we have a clean and complete submission.
3. **Coding Mechanics and Descriptor Differentiation.** Could you assess whether the proposed descriptor adequately captures the proprietary TRI algorithm component? This element is central to our reimbursement rate premium justification — the team is targeting a Medicare reimbursement rate of $3,850 per test, representing a premium over the weighted average of crosswalk comparators, justified in part by the proprietary nature of the TRI algorithm. The crosswalk comparators currently under consideration are:
- PLA Code 0250U — Elara Genomic Sciences, "GeneSight Onco-48" ($3,742) - CPT Code 81455 — NGS, solid organ neoplasm, 51+ genes ($2,919) - PLA Code 0239U — Marlowe Asset Management Molecular Diagnostics, "TumorMap Pro" ($4,206)
I'd like your view on whether the descriptor language as drafted will adequately support differentiation from these comparators for crosswalk pricing purposes.
4. **Supporting Documentation Completeness.** Finally, could you please flag any supporting documentation items that should be included in or appended to the PLA application that the current draft may be missing? I want to make sure we are aligned with AMA's recent guidance on PLA submissions, and I defer to your judgment on what the Editorial Panel will expect to see in the package.
**Timeline and Next Steps**
To allow Sean and me sufficient time to incorporate your feedback before the March 22 delivery to GDT, could you please provide your comments and any redline edits by **close of business Wednesday, March 20**? I know that is a quick turnaround, and I appreciate your flexibility.
Kevin Driscoll, GDT's VP of Market Access & Reimbursement, is copied here for visibility. Kevin has been the day-to-day point person on this engagement and may have additional input on the clinical or laboratory details reflected in the application.
Following GDT's review and approval of the draft, we will finalize the application for submission ahead of the June 28 deadline. I anticipate at least one more round of revisions before we reach a final version. Separately, we are also preparing a draft cover letter to accompany the PLA application submission to the AMA CPT Editorial Panel, which we will circulate to you shortly.
Janet, thank you as always for your collaboration on this workstream — your guidance on the coding side has been invaluable. If you would prefer to discuss any aspects of the draft by phone rather than providing written comments, I am happy to set up a call at your convenience. I am available throughout this week and can be reached directly at (415) 692-3847.
Best regards,
Christopher Aiken Associate Healthcare & Life Sciences Practice Calderwood & Harkness LLP 555 California Street, Suite 3200 San Francisco, CA 94104 T: (415) 692-3847 E: caiken@calderwoodharkness.com
---
CONFIDENTIALITY NOTICE: This email message, including any attachments, is for the sole use of the intended recipient(s) and may contain confidential, privileged, and/or proprietary information protected by the attorney-client privilege, the work product doctrine, or other applicable law. If you are not the intended recipient, you are hereby notified that any review, use, disclosure, dissemination, distribution, or copying of this communication is strictly prohibited. If you have received this communication in error, please notify the sender immediately by reply email and permanently delete the original message and all copies. Thank you.