CALDERWOOD & HARKNESS LLP Attorneys at Law
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| Telephone: (202) 555-7400 | Facsimile: (202) 555-7401 www.calderwoodharkness.com |
Federal Tax ID / EIN: 52-1843976
Invoice Date: March 15, 2024
Bill To:
Genome Dx Therapeutics Inc.
Attn: Theresa Nakamura, General Counsel & VP of Regulatory Affairs
4720 Torrey Pines Road, Suite 300 San Diego, CA 92130 EIN: 83-2947156
Summary of Charges
Professional Services — Timekeeper Summary
For services rendered during the period February 14, 2024 through March 14, 2024:
Professional Services — Detail
The following is a chronological description of professional services rendered during the billing period. All time is recorded in increments of one-tenth (0.1) of an hour.
February 14, 2024
Miriam Calloway (MLC) — 1.5 hrs — $2,025.00
Review executed engagement letter and scope of representation for Medicare coverage and coding strategy for OncoPrecise GXP-47 next-generation sequencing diagnostic panel. Initial conference with J. Strauss regarding matter staffing and workstream planning, including identification of key team members and allocation of responsibilities across coding, coverage, and reimbursement workstreams. Review GDT background materials including corporate overview, organizational structure, and regulatory credentials, specifically CLIA certification (No. 05D2187432), CAP accreditation (No. 9074821), NPI (1902847365), and OncoPrecise platform patent portfolio encompassing 14 issued U.S. patents and 7 pending applications covering the proprietary Therapy Response Index algorithm and associated gene expression measurement methodologies.
Sean Morrissey (SPM) — 2.0 hrs — $1,750.00
Review engagement letter and scope documents provided by client. Begin assembling regulatory background file on Medicare coverage pathways for NGS-based oncology diagnostics, including overview of applicable statutory authority under 42 U.S.C. § 1395x and implementing regulations at 42 C.F.R. Part 410. Review existing Local Coverage Determination LCD L38472 for OncoPrecise GXP-12 (effective August 15, 2021, issued by Cascade Fiscal Intermediaries, LLC, for Jurisdiction E — California), analyzing coverage criteria, clinical indications, and limitations of coverage as they may inform strategy for GXP-47 panel. Identify key regulatory milestones and deadlines for PLA code application targeting the AMA CPT Editorial Panel September 2024 meeting, noting application submission deadline of June 28, 2024.
Christopher Aiken (CJA) — 1.5 hrs — $975.00
Review engagement materials and matter scope documents. Begin research on AMA CPT Editorial Panel Proprietary Laboratory Analyses (PLA) code application requirements and submission procedures, including review of the AMA's current PLA Code Application Guidance document and supplementary instructions for molecular diagnostic tests. Review GDT's CLIA certificate of compliance and CAP laboratory accreditation certificate for completeness, verifying active status and scope of accreditation categories relevant to high-complexity molecular testing.
Danielle M. Russo (Paralegal) — 0.5 hrs — $187.50
Open new matter file (Matter No. 1043-00002, Client No. 47832) in firm's document management system. Set up document management folders organized by workstream, including subfolders for client correspondence, regulatory filings, coding analysis, coverage strategy, reimbursement analysis, and meeting materials. Index initial client-provided documents and assign Bates prefixes for document tracking.
February 15–16, 2024
Sean Morrissey (SPM) — 3.5 hrs — $3,062.50
Research current Medicare coverage landscape for NGS-based oncology diagnostic tests, including comprehensive survey of existing Local Coverage Determinations and National Coverage Determinations applicable to molecular diagnostic panels. Identify and analyze relevant NCDs, including NCD 90.2 (Next Generation Sequencing for Medicare Beneficiaries with Advanced Cancer, effective March 16, 2018, as revised), evaluating scope and limitations as applied to laboratory-developed tests such as OncoPrecise GXP-47. Survey MolDx program requirements as administered by Ridgeline Administrative Services, LLC, the MolDx contractor for Cascade Fiscal Intermediaries, LLC; identify Dr. Catherine Embry as MolDx Technical Assessment Director responsible for evaluating molecular diagnostic test submissions within Jurisdiction E. Research recent CMS policy developments affecting genomic diagnostics, including the January 2024 CMS proposed rule on reconsideration of the NCD framework for precision medicine diagnostics and the ongoing Medicare Administrative Contractor consolidation affecting molecular pathology claims processing.
Christopher Aiken (CJA) — 2.5 hrs — $1,625.00
Research PLA code versus CPT code pathways for proprietary laboratory-developed tests, analyzing the relative advantages and disadvantages of each approach for a novel RNA expression-based oncology diagnostic panel. Review AMA PLA code application format and study precedent submissions available through the AMA's public CPT coding resource library. Compile list of existing PLA codes for oncology NGS panels, including PLA Code 0250U (Elara Genomic Sciences, Inc., "GeneSight Onco-48," 48-gene DNA mutation panel for solid tumor profiling) and PLA Code 0239U (Marlowe Asset Management Molecular Diagnostics, Inc., "TumorMap Pro," 52-gene combined DNA/RNA panel for tumor characterization), analyzing descriptor language, test methodology descriptions, and specimen requirements for each as potential models for GXP-47 submission.
February 19–21, 2024
Miriam Calloway (MLC) — 2.0 hrs — $2,700.00
Telephone conference with Theresa Nakamura, GDT General Counsel, regarding OncoPrecise GXP-47 clinical development status, including discussion of CLARITY-LUNG trial (ClinicalTrials.gov Identifier NCT05891247) enrollment progress as of February 2024. Review current enrollment figures (approximately 480 of 1,200 planned patients enrolled across 37 trial sites in the United States and Canada) and discuss timeline expectations for reaching 50% enrollment milestone (projected for Q3 2024) and corresponding interim analysis. Discuss LCD filing strategy with Cascade Fiscal Intermediaries, LLC (Jurisdiction E — California), including consideration of whether to pursue LCD through the standard reconsideration process to expand existing LCD L38472 or to submit a new LCD request for GXP-47 as a distinct test with differentiated clinical indications. Review GDT board composition and discuss implications of Pinnacle Health Ventures' Series B investment terms, including board observer rights over commercialization decisions and potential impact on coverage and reimbursement strategy decisions requiring board-level approval.
Sean Morrissey (SPM) — 3.0 hrs — $2,625.00
Continue LCD regulatory landscape research. Draft sections of the LCD Regulatory Landscape Memorandum addressing MolDx program technical assessment requirements, including detailed outline of dossier content expectations organized by the five core evidentiary domains: (1) test description and intended use; (2) analytical validation data and performance characteristics; (3) clinical validation studies demonstrating association between test results and clinical outcomes; (4) clinical utility evidence demonstrating impact on patient management and health outcomes; and (5) health economic analysis including cost-effectiveness and budget impact modeling. Review Cascade Fiscal Intermediaries' prior LCD decisions for molecular diagnostic tests issued within the past 24 months, identifying patterns in evidentiary standards applied and common deficiency findings. Identify Dr. William Hargrove, Medical Director, and Sandra Phu, LCD Analyst, as key personnel at CFI responsible for molecular diagnostic LCD review and public comment processes.
Christopher Aiken (CJA) — 2.0 hrs — $1,300.00
Continue PLA code versus CPT code analysis. Draft initial comparison framework examining advantages of proprietary PLA code pathway (single-laboratory exclusivity ensuring that the PLA code maps exclusively to GDT's OncoPrecise GXP-47 test, descriptor specificity capturing the proprietary TRI algorithm and 47-gene expression panel, and enhanced marketing and payer recognition value) versus stacking existing CPT codes (specifically CPT 81455 — next-generation sequencing, solid organ neoplasm, DNA and RNA analysis, 51 or greater genes, interrogation for sequence variants, gene copy number, and microsatellite instability). Research reimbursement rate implications of each pathway, including analysis of CMS Clinical Laboratory Fee Schedule pricing for CPT 81455 (current national rate of $2,919.00) compared with potential gap-fill pricing methodology applicable to new PLA codes during the initial coverage period.
Joel Strauss (JES) — 1.5 hrs — $1,912.50
Review initial regulatory landscape research prepared by S. Morrissey and C. Aiken. Conference with M. Calloway regarding FDA/CMS regulatory intersection for laboratory-developed tests, with particular attention to the potential impact of the FDA's proposed rule (88 FR 68006, published October 3, 2023) concerning regulation of laboratory-developed tests under the Medical Device Amendments framework. Advise on potential implications of proposed phased enforcement timeline for GDT's coverage strategy, including whether anticipated FDA oversight could affect the MolDx technical assessment process or alter evidentiary standards applied by Cascade Fiscal Intermediaries for LCD review of LDTs.
Danielle M. Russo (Paralegal) — 1.0 hr — $375.00
Compile and organize research materials received from S. Morrissey and C. Aiken. Prepare document indices for client-provided clinical and regulatory files, including indexing of 47 documents received from GDT encompassing analytical validation study data, CLARITY-LUNG trial protocol and amendments, CLIA and CAP certification documentation, patent portfolio summary, and corporate organizational materials. Cross-reference indexed documents against matter file organizational structure.
February 22–27, 2024
Miriam Calloway (MLC) — 2.5 hrs — $3,375.00
Prepare detailed agenda for February 28 project kickoff meeting, including identification of discussion topics, presentation assignments, and proposed workstream allocations. Conference call with Kevin Driscoll, GDT Vice President of Market Access & Reimbursement, to discuss coordination protocol with outside consultants retained by GDT, specifically Carraway Regulatory Advisors, Inc. (Janet Carraway, Principal, coding and CPT/PLA application consultant) and Larkfield Health Economics, LLC (Dr. Nathan Ostroff, Ph.D., health economics and outcomes research consultant). Discuss roles and responsibilities among Calderwood & Harkness, Carraway, and Larkfield to avoid duplication of effort and ensure integrated strategy development. Review OncoPrecise GXP-47 test specifications in detail, including 47-gene RNA expression panel methodology using FFPE NSCLC tissue specimens, proprietary bioinformatics pipeline, and composite Therapy Response Index (TRI) score output (continuous scale 0–100 with three patient stratification categories: High Response Likelihood ≥70, Intermediate Response Likelihood 40–69, and Low Response Likelihood <40), designed to guide immunotherapy (ICI) versus platinum-based chemotherapy treatment selection in patients with Stage IIIB/IV non-small-cell lung cancer.
Sean Morrissey (SPM) — 4.0 hrs — $3,500.00
Continue drafting LCD Regulatory Landscape Memorandum. Compile comprehensive overview of MolDx program submission requirements, including detailed analysis of required dossier sections and formatting specifications. Analyze precedent technical assessments for multi-gene oncology panels, reviewing publicly available MolDx assessment summaries for three comparable diagnostic tests and identifying common evidentiary strengths and weaknesses cited by the MolDx assessment team. Review OncoPrecise GXP-47 analytical validation publication authored by Dr. Priya Sundaram et al. (Journal of Molecular Oncology Diagnostics, Vol. 18, Issue 4, pp. 412–429, December 2022), analyzing reported analytical performance characteristics including limit of detection, reproducibility, inter-laboratory concordance, and specimen input requirements. Prepare kickoff meeting materials, including preliminary project timeline identifying key milestones: PLA code application submission (June 28, 2024), LCD pre-submission meeting request (July 2024), MolDx dossier submission (August 2024), and projected LCD effective date (Q1 2025).
Christopher Aiken (CJA) — 3.0 hrs — $1,950.00
Continue drafting PLA versus CPT code analysis incorporating additional research on reimbursement implications and payer recognition factors. Research AMA CPT Editorial Panel meeting schedule, confirming September 2024 panel meeting dates (September 12–14, 2024) and associated application deadlines. Draft proposed PLA code descriptor language for OncoPrecise GXP-47, including test name, manufacturer identification, specimen type, methodology description, and clinical indication, modeled on approved PLA code descriptors for comparable molecular diagnostic tests. Prepare kickoff meeting presentation materials on coding pathway options, including comparative slide deck summarizing PLA versus CPT advantages, risks, timeline considerations, and reimbursement projections.
Joel Strauss (JES) — 1.0 hr — $1,275.00
Review kickoff meeting agenda prepared by M. Calloway. Provide input on scope of National Coverage Determination feasibility assessment and Coverage with Evidence Development (CED) framework analysis to be discussed at kickoff meeting, including preliminary assessment of whether CED pathway could provide accelerated national coverage pending completion of CLARITY-LUNG trial. Review relevant CMS guidance documents on CED program requirements under 42 C.F.R. § 405.207.
Danielle M. Russo (Paralegal) — 1.5 hrs — $562.50
Prepare and distribute kickoff meeting agenda and background packages to all confirmed attendees. Coordinate scheduling across multiple organizations, confirming availability and distributing calendar invitations and videoconference access information to GDT participants (Theresa Nakamura, Kevin Driscoll, Dr. Priya Sundaram, and Raymond Ota, Director of Laboratory Operations), Carraway Regulatory Advisors (Janet Carraway), and Larkfield Health Economics (Dr. Nathan Ostroff). Compile and distribute meeting pre-read package including engagement scope summary, preliminary project timeline, and coding pathway overview.
February 28, 2024
Miriam Calloway (MLC) — 3.0 hrs — $4,050.00
Attend and lead project kickoff meeting via videoconference with full project team: GDT representatives (Theresa Nakamura, General Counsel; Kevin Driscoll, VP of Market Access & Reimbursement; Dr. Priya Sundaram, Chief Scientific Officer; Raymond Ota, Director of Laboratory Operations); Carraway Regulatory Advisors (Janet Carraway, Principal); and Larkfield Health Economics (Dr. Nathan Ostroff, Principal). Facilitate discussion of project scope encompassing four integrated workstreams: (1) PLA code application preparation and submission; (2) LCD/MolDx coverage strategy and dossier development; (3) NCD pathway assessment and CED feasibility analysis; and (4) reimbursement rate modeling and payer engagement strategy. Review OncoPrecise GXP-47 test characteristics and intended clinical use in guiding selection between immune checkpoint inhibitor therapy and platinum-based chemotherapy in patients with Stage IIIB/IV NSCLC. Discuss CLARITY-LUNG trial (NCT05891247) enrollment status (approximately 480 of 1,200 patients enrolled) and projected interim analysis timeline at 50% enrollment (n=600), expected in Q3 2024. Assign workstream responsibilities: Calderwood & Harkness to lead PLA code application (with Carraway collaboration), LCD/MolDx strategy, and NCD/CED assessment; Larkfield to lead health economic analysis in coordination with Calderwood & Harkness; Carraway to provide CPT/PLA coding expertise and application drafting support. Confirm PLA code application timeline targeting AMA CPT Editorial Panel September 2024 meeting with application submission deadline of June 28, 2024, and LCD filing target of August 2024 for Cascade Fiscal Intermediaries Jurisdiction E. Post-meeting debrief with Calderwood & Harkness team members to discuss key takeaways, assess project risks, and confirm internal deadlines.
Joel Strauss (JES) — 1.0 hr — $1,275.00
Attend project kickoff meeting. Provide input on NCD pathway considerations, including analysis of whether GXP-47's clinical positioning as a companion diagnostic for ICI therapy selection may implicate existing NCD 90.2 coverage criteria or require separate NCD request. Discuss FDA regulatory landscape for laboratory-developed tests and potential implications of proposed LDT rulemaking for coverage strategy timeline.
Sean Morrissey (SPM) — 3.5 hrs — $3,062.50
Attend project kickoff meeting; serve as primary note-taker documenting all attendees, agenda items, discussion points, strategic decisions, and action items. Capture detailed notes on client's preferred timeline, risk tolerance regarding clinical evidence maturity, and coordination requirements with ongoing CLARITY-LUNG trial data monitoring. Post-meeting: draft comprehensive kickoff meeting minutes organized by workstream, documenting all decisions reached and action items assigned with responsible parties and target completion dates. Update project timeline tracker with confirmed milestones, deadlines, and interdependencies across workstreams.
Christopher Aiken (CJA) — 2.5 hrs — $1,625.00
Attend project kickoff meeting. Present preliminary PLA code versus CPT code analysis to full project team, including summary of advantages and risks of each coding pathway and preliminary recommendation favoring PLA code approach. Discuss proposed PLA code descriptor language with Janet Carraway (Carraway Regulatory Advisors), incorporating Carraway's feedback on descriptor formatting conventions and AMA editorial preferences for molecular diagnostic test descriptors. Post-meeting: revise coding analysis to incorporate discussion feedback, including Carraway's recommendation to emphasize the proprietary TRI algorithm and FFPE specimen type in the descriptor to differentiate GXP-47 from existing stacked CPT code options.
Danielle M. Russo (Paralegal) — 1.0 hr — $375.00
Attend project kickoff meeting in note-taking support capacity. Distribute meeting materials to attendees at commencement of meeting. Begin compiling post-meeting action item tracker cross-referenced to workstream assignments, responsible parties, and target completion dates.
March 1–5, 2024
Sean Morrissey (SPM) — 4.0 hrs — $3,500.00
Finalize kickoff meeting minutes and circulate to all project team members and client representatives for review and comment. Continue drafting LCD Regulatory Landscape Memorandum, incorporating insights and strategic direction confirmed at kickoff meeting. Research recent MolDx technical assessment outcomes for oncology NGS panels, reviewing three publicly available MolDx assessment summaries issued by Ridgeline Administrative Services between January 2023 and January 2024 for multi-gene expression panels with companion diagnostic indications. Analyze implications of Ridgeline Administrative Services' evidentiary standards for clinical validation data, noting the MolDx program's emphasis on prospective clinical validation or, at minimum, prospective-retrospective study designs using pre-specified analysis plans, and assess how GDT's available clinical evidence (CLARITY-LUNG trial interim data and retrospective validation study) aligns with these standards.
Christopher Aiken (CJA) — 3.0 hrs — $1,950.00
Revise and expand PLA code versus CPT code analysis incorporating feedback from kickoff meeting and specific input from Janet Carraway (Carraway Regulatory Advisors) regarding AMA PLA code descriptor conventions and recent editorial panel trends favoring descriptors that clearly identify the proprietary algorithm or scoring methodology. Draft detailed comparison of reimbursement implications, including analysis of current CMS Clinical Laboratory Fee Schedule national limitation amount for CPT 81455 ($2,919.00 per test) versus PLA code pathway with expected higher reimbursement potential through gap-fill pricing methodology, under which the MAC establishes an initial payment rate based on charges, resources, and comparable existing tests during the first year, typically resulting in rates 15–40% above stacked CPT code pricing for novel proprietary tests. Begin drafting Coding Strategy Memorandum for client delivery.
Miriam Calloway (MLC) — 1.5 hrs — $2,025.00
Review draft LCD Regulatory Landscape Memorandum prepared by S. Morrissey. Provide substantive edits and strategic guidance, including recommendations on the memorandum's analysis of MolDx evidentiary standards and the memorandum's assessment of timing considerations for LCD filing relative to CLARITY-LUNG trial interim analysis data availability. Telephone conference with Theresa Nakamura regarding CLARITY-LUNG trial enrollment update, including discussion of Dr. Sundaram's projected timeline for interim analysis at 50% enrollment (n=600 patients, currently projected for late August or early September 2024) and implications for LCD filing timeline.
March 6–10, 2024
Sean Morrissey (SPM) — 4.0 hrs — $3,500.00
Finalize LCD Regulatory Landscape Memorandum. Research and draft remaining sections analyzing existing LCDs for comparable NGS-based oncology diagnostics, including comparative analysis of LCD coverage criteria, clinical indications, and limitations of coverage across five active LCDs in Jurisdictions E, F, and JE for molecular diagnostic tests with companion diagnostic or therapy selection indications. Review Cascade Fiscal Intermediaries' published coverage policies and procedures for Jurisdiction E, including LCD development and reconsideration process timelines, public comment period requirements, and evidentiary review committee composition and meeting schedules. Prepare final memorandum for partner review, including executive summary, strategic recommendations, and appendices containing LCD comparison tables and MolDx submission checklist.
Christopher Aiken (CJA) — 3.0 hrs — $1,950.00
Finalize Coding Strategy Memorandum for client delivery. Incorporate detailed analysis of 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." Include recommendation favoring PLA code pathway over stacked CPT coding approach, supported by analysis of four primary advantages: (1) single-laboratory exclusivity ensuring reimbursement specificity; (2) descriptor specificity capturing proprietary TRI algorithm and differentiated test methodology; (3) enhanced payer recognition and reduced claim adjudication complexity; and (4) support for premium reimbursement rate through gap-fill pricing mechanism. Address risks of PLA pathway, including longer timeline to national pricing establishment and potential for initial geographic variability in MAC gap-fill rates.
Miriam Calloway (MLC) — 2.0 hrs — $2,700.00
Review and edit Coding Strategy Memorandum (PLA Code vs. CPT Code Analysis for OncoPrecise GXP-47) in final form. Provide substantive comments on reimbursement rate analysis and risk assessment sections. Approve memorandum for delivery to client. Conference with S. Morrissey regarding LCD strategy considerations, including discussion of optimal timing for LCD pre-submission meeting request to Cascade Fiscal Intermediaries and coordination of LCD filing with PLA code application timeline to ensure coding infrastructure is in place in advance of coverage determination.
Joel Strauss (JES) — 1.0 hr — $1,275.00
Review Coding Strategy Memorandum in final form. Provide comments on FDA/CMS regulatory considerations relevant to PLA code descriptor language, including analysis of whether the proposed descriptor's reference to the "algorithm-derived Therapy Response Index (TRI) score" could implicate FDA software as a medical device (SaMD) classification considerations and whether any such classification risk should be addressed in the client memorandum or reserved for the NCD/CED workstream analysis.
Danielle M. Russo (Paralegal) — 0.8 hrs — $300.00
Finalize formatting and cite-checking of Coding Strategy Memorandum for client delivery, including verification of all regulatory citations, CPT code references, PLA code examples, and CLIA/CAP/NPI numbers referenced in the memorandum. Prepare transmittal correspondence to Theresa Nakamura and Kevin Driscoll for M. Calloway's signature.
March 11, 2024
Miriam Calloway (MLC) — 1.0 hr — $1,350.00
Deliver Coding Strategy Memorandum (PLA Code vs. CPT Code Analysis for OncoPrecise GXP-47) to GDT (Theresa Nakamura, General Counsel, and Kevin Driscoll, VP of Market Access & Reimbursement) via secure client portal with transmittal letter. Conference call with client to discuss memorandum recommendations, including Calderwood & Harkness's recommendation to pursue PLA code pathway, proposed descriptor language, reimbursement rate projections under gap-fill pricing, and next steps for PLA code application preparation in coordination with Carraway Regulatory Advisors. Discuss preliminary timeline for application drafting and internal GDT review cycle targeting completion of application package by mid-June 2024 to allow adequate review time before June 28 submission deadline.
Sean Morrissey (SPM) — 1.0 hr — $875.00
Participate in client conference call regarding delivery and discussion of Coding Strategy Memorandum. Take notes on client feedback and questions, including GDT's request for additional analysis of commercial payer coverage implications of PLA code versus stacked CPT coding. Discuss next steps for PLA code application drafting, including coordination protocol with Janet Carraway (Carraway Regulatory Advisors) for application preparation, and plan for concurrent initiation of MolDx Technical Assessment Dossier framework development.
March 12–14, 2024
Christopher Aiken (CJA) — 2.0 hrs — $1,300.00
Begin drafting PLA code application for OncoPrecise GXP-47 for submission to AMA CPT Editorial Panel. Prepare initial sections of the application, including test methodology description (47-gene RNA expression profiling using next-generation sequencing of formalin-fixed paraffin-embedded non-small-cell lung cancer tissue with proprietary bioinformatics algorithm generating composite Therapy Response Index score), clinical indications (patients with Stage IIIB or Stage IV NSCLC who are candidates for first-line systemic therapy, for prediction of response to immune checkpoint inhibitor therapy), specimen type and handling requirements (FFPE tissue, minimum 10mm² section area, minimum 20% tumor cellularity), and laboratory information sections (Genome Dx Therapeutics Inc., CLIA Certificate No. 05D2187432, NPI 1902847365, CAP Accreditation No. 9074821, laboratory address 4720 Torrey Pines Road, Suite 300, San Diego, CA 92130). Coordinate with Janet Carraway (Carraway Regulatory Advisors) on AMA application formatting requirements and section-specific content expectations.
Sean Morrissey (SPM) — 2.0 hrs — $1,750.00
Begin research and preliminary framework development for MolDx Technical Assessment Dossier, the core evidentiary submission required by Ridgeline Administrative Services to support LCD development by Cascade Fiscal Intermediaries. Review clinical validation data currently available from the CLARITY-LUNG trial (NCT05891247), including published trial design, primary and secondary endpoints, patient stratification schema based on TRI score categories, and enrollment projections. Review prior retrospective validation study results (Sundaram et al., multi-institutional retrospective cohort, N=312, published in Clinical Cancer Genomics, Vol. 7, Issue 2, pp. 89–103, March 2023) assessing association between GXP-47 TRI score categories and objective response rate to ICI therapy. Assess evidentiary requirements for clinical utility demonstration under MolDx program standards, identifying potential gaps in currently available evidence and developing strategy for addressing identified gaps through supplementary analyses and/or CLARITY-LUNG interim data.
Danielle M. Russo (Paralegal) — 1.0 hr — $375.00
Compile supporting documentation for PLA code application, including certified copies of GDT's CLIA certificate of compliance (No. 05D2187432, issued by CMS, effective through November 30, 2025), CAP laboratory accreditation certificate (No. 9074821, most recent inspection date October 12, 2023), and NPI verification printout from NPPES database (NPI 1902847365, enumeration date March 15, 2019). Organize analytical validation publication (Sundaram et al., J. Mol. Oncol. Diagn., 2022) and supporting literature into application appendix format with document index and pagination.
Disbursements
No disbursements were incurred during this billing period.
Invoice Summary
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Please reference Invoice No. INV-1043-00002-001 and Matter No. 1043-00002 on all remittances.
Terms and Conditions
Interest will accrue on all amounts unpaid after the due date at a rate of 1.0% per month (12.0% per annum), or the maximum rate permitted by applicable law, whichever is less. This invoice is rendered pursuant to and subject to the terms and conditions set forth in the Engagement Letter between Calderwood & Harkness LLP and Genome Dx Therapeutics Inc. dated February 14, 2024, which governs the scope, terms, and conditions of this engagement. In the event of any conflict between the terms of this invoice and the Engagement Letter, the Engagement Letter shall control.
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For billing inquiries, please contact:
Joel Strauss, Billing Partner Calderwood & Harkness LLP 375 Park Avenue, 30th Floor New York, NY 10152 Telephone: (212) 555-3120
Email: j.strauss@calderwoodharkness.com
— PAID — Payment received in full.
| Invoice Number: | INV-1043-00002-001 | |||
| Client Number: | 47832 | |||
| Matter Number: | 1043-00002 | |||
| Matter Description: | Medicare Coverage & Coding Strategy — OncoPrecise GXP-47 | |||
| Billing Period: | February 14, 2024 – March 14, 2024 | |||
| Payment Terms: | Net 30 Days from Invoice Date | |||
| Payment Due Date: | April 14, 2024 | |||
| Billing Partner: | Joel Strauss | |||
| Responsible Partner: | Miriam Calloway | |||
| Total Professional Fees | $62,437.50 | |||
| Total Disbursements / Costs | $0.00 | |||
| Total Current Charges | $62,437.50 | |||
| Prior Balance | $0.00 | |||
| Payments / Credits | $0.00 | |||
| Total Amount Due | $62,437.50 | |||
| Timekeeper | Title | Rate ($/hr) | Hours | Amount |
| Miriam Calloway | Partner | $1,350.00 | 13.5 | $18,225.00 |
| Joel Strauss | Partner | $1,275.00 | 4.5 | $5,737.50 |
| Sean Morrissey | Senior Associate | $875.00 | 27.0 | $23,625.00 |
| Christopher Aiken | Associate | $650.00 | 19.5 | $12,675.00 |
| Danielle M. Russo | Paralegal | $375.00 | 5.8 | $2,175.00 |
| Totals | 70.3 | $62,437.50 | ||
| Total Disbursements | $0.00 | |||
| Total Professional Fees | $62,437.50 | |||
| Total Disbursements | $0.00 |
| Total Current Charges | $62,437.50 |
| Previous Balance | $0.00 |
| Payments / Credits | $0.00 |
| TOTAL AMOUNT DUE | $62,437.50 |
| Payment Due Date | April 14, 2024 |
| Bank: | Meridian Trust Bank, N.A. |
| ABA Routing Number: | 021-084-736 |
| Account Name: | Calderwood & Harkness LLP — Operating Account |
| Account Number: | 8841-5027-3390 |
| Reference: | Invoice No. INV-1043-00002-001 / Matter No. 1043-00002 |