CALDERWOOD & HARKNESS LLP Attorneys at Law
1700 K Street NW, Suite 900 Washington, DC 20006
Telephone: (202) 861-7400 Facsimile: (202) 861-7401 www.calderwoodharkness.com
February 6, 2024
VIA EMAIL AND OVERNIGHT COURIER
Theresa Nakamura, Esq. General Counsel & Vice President of Regulatory Affairs Genome Dx Therapeutics Inc. 4720 Torrey Pines Road, Suite 300 San Diego, CA 92130
Re: Response to Request for Proposals — Medicare Coverage and Coding Counsel for OncoPrecise GXP-47 Reference: GDT RFP dated January 22, 2024
Dear Ms. Nakamura:
I. Introduction and Executive Summary
On behalf of Calderwood & Harkness LLP, I am pleased to submit this proposal in response to Genome Dx Therapeutics Inc.'s ("GDT" or the "Company") Request for Proposals dated January 22, 2024, seeking Medicare coverage and coding counsel for OncoPrecise GXP-47. My name is Miriam Calloway, and I am a Partner in Calderwood & Harkness's Healthcare & Life Sciences practice group. I have been asked to lead this engagement proposal, and I write on behalf of the firm and the proposed engagement team described herein.
We appreciate the opportunity to present our qualifications for this important assignment. GDT is at a pivotal moment in the commercialization trajectory of what we understand to be a highly promising next-generation sequencing-based genomic diagnostic, and the Medicare coverage and coding strategy that GDT establishes now will have a profound and enduring effect on the test's commercial success, the Company's revenue profile, and GDT's positioning with both institutional and commercial payers going forward. We do not take the significance of this engagement lightly.
Based on our review of the RFP and our preliminary analysis of the regulatory and reimbursement landscape for OncoPrecise GXP-47, we understand the core objective of the engagement as follows: to develop and execute a comprehensive Medicare coverage and coding strategy for OncoPrecise GXP-47, a 47-gene RNA expression panel genomic diagnostic test designed to predict treatment response in patients with advanced non-small-cell lung cancer ("NSCLC"). OncoPrecise GXP-47 is a laboratory-developed test ("LDT") performed exclusively at GDT's CLIA-certified reference laboratory in San Diego, California, and produces a proprietary composite Therapy Response Index ("TRI") score that stratifies patients by their likelihood of response to immune checkpoint inhibitor therapy.
The scope of this engagement, as we understand it, encompasses four principal objectives that together constitute the foundational reimbursement infrastructure for OncoPrecise GXP-47:
First, obtaining a unique Proprietary Laboratory Analyses ("PLA") code through the American Medical Association ("AMA") CPT Editorial Panel that accurately captures the proprietary nature of GDT's test and positions the test for premium reimbursement relative to generic Next-Generation Sequencing ("NGS") codes.
Second, securing a favorable local coverage determination ("LCD") from the applicable Medicare Administrative Contractor — in this case, Cascade Fiscal Intermediaries, LLC ("CFI"), which administers claims under the MolDx program for Jurisdiction E, covering California — supported by a comprehensive MolDx technical assessment dossier submitted to the MolDx program administrator, Ridgeline Administrative Services, LLC.
Third, establishing a Medicare reimbursement rate that reflects the clinical value and analytical sophistication of OncoPrecise GXP-47 through the crosswalk and gapfill pricing methodology applicable to new laboratory tests under the Clinical Laboratory Fee Schedule ("CLFS").
Fourth, evaluating and, as appropriate, navigating CMS national coverage determination ("NCD") pathways, including the traditional NCD process and the Coverage with Evidence Development ("CED") framework, to position OncoPrecise GXP-47 for nationwide Medicare coverage when supported by the clinical evidence base.
In addition to these core workstreams, we propose to serve as GDT's ongoing strategic advisors on Medicare coverage and reimbursement matters related to OncoPrecise GXP-47, including preparation of materials for board-level presentations, coordination with GDT's other advisors, and monitoring of relevant CMS policy developments.
Calderwood & Harkness maintains offices in New York (our headquarters, located at 375 Park Avenue, 30th Floor, New York, NY 10152), Washington, D.C., Los Angeles, and San Francisco. This geographic footprint provides substantial flexibility for an engagement of this nature — our Washington, D.C. office offers proximity to CMS headquarters in Baltimore and to the AMA's coding proceedings, while our San Francisco office ensures accessibility to GDT's California-based operations and to CFI's Jurisdiction E operations.
We are confident that Calderwood & Harkness's deep experience in Medicare coverage for molecular diagnostics and genomic testing — and the specific qualifications of the team we propose to assign to this engagement — make our firm uniquely suited to serve as GDT's counsel for the commercialization of OncoPrecise GXP-47. The balance of this proposal sets forth our qualifications, our understanding of the Company and its test, our proposed scope of work, timeline, fee estimate, and the reasons we believe Calderwood & Harkness is the right choice for this engagement.
II. Firm Overview and Healthcare & Life Sciences Practice Qualifications
About Calderwood & Harkness LLP
Calderwood & Harkness LLP is a national law firm organized as a Limited Liability Partnership under the laws of the State of New York. The firm maintains a broad platform of legal services across a number of practice areas, but our Healthcare & Life Sciences practice group is among the most well-established and deeply resourced teams in the firm, and it is this group that would be responsible for GDT's engagement.
The Healthcare & Life Sciences Practice Group
Our Healthcare & Life Sciences practice group is a dedicated, multidisciplinary team that handles a wide range of matters at the intersection of healthcare regulation, life sciences innovation, and government program reimbursement. The group's core competencies include:
• FDA regulatory counsel — advising manufacturers, developers, and laboratories on the regulatory classification and market authorization of diagnostics, medical devices, and pharmaceutical products, including the evolving FDA framework for laboratory-developed tests;
• CMS coverage and reimbursement — representing diagnostic and therapeutic companies in local and national coverage determination proceedings before Medicare Administrative Contractors and CMS, including strategy development, dossier preparation, comment period advocacy, and post-decision implementation;
• Health technology assessment — counseling clients on the evidentiary standards and decision frameworks applied by CMS, MolDx program administrators, and other HTA bodies, including the analytical requirements for clinical validity, clinical utility, and health economic analysis;
• Life sciences regulatory matters — advising on CLIA and CAP laboratory compliance, billing and coding compliance under the Medicare Clinical Laboratory Fee Schedule, fraud and abuse considerations applicable to laboratory services, and state laboratory licensure requirements; and
• Commercialization-stage strategy — working closely with venture-backed and private equity-backed biotechnology and diagnostics companies as they transition from development-stage to commercial-stage, with particular attention to the reimbursement and coverage infrastructure that underpins commercialization success.
Track Record in Molecular Diagnostics Coverage
The Healthcare & Life Sciences team has a strong track record of representation in the specific area most relevant to GDT's engagement: Medicare coverage proceedings for molecular diagnostics and genomic testing platforms. Over the past decade, the team has represented clinical-stage molecular diagnostics companies, genomics companies, and reference laboratories in a substantial number of LCD and NCD proceedings before MACs and CMS, across range clinical indications and testing modalities including NGS panels, gene expression profiling assays, pharmacogenomic tests, and companion diagnostics.
Miriam Calloway, the proposed Responsible Partner for this engagement, has personally been involved in more than fifteen LCD and NCD proceedings before MACs and CMS over the course of her twenty-eight years of practice in Medicare coverage and reimbursement law. Her experience includes matters involving the full spectrum of coverage proceedings, from initial LCD requests and MolDx technical assessments through open meeting testimony, comment period submissions, reconsideration requests, and, where necessary, administrative law judge proceedings under the Medicare appeals framework.
Specific MolDx Program Experience
Of particular relevance to GDT's engagement, our team has substantial experience with the MolDx program technical assessments administered by contractors including Ridgeline Administrative Services, LLC, which serves as the MolDx program administrator. The MolDx program imposes rigorous evidentiary standards on molecular diagnostic tests seeking Medicare coverage, and the technical assessment dossier is the central document on which coverage decisions turn. Our team has prepared and successfully prosecuted MolDx dossiers for multiple genomic diagnostic platforms, and we have developed a deep understanding of the program's analytical framework, the types and quality of clinical evidence that Ridgeline's technical reviewers expect, and the common deficiency areas that can delay or derail coverage determinations.
AMA CPT Editorial Panel PLA Code Experience
Our team also has direct experience with AMA CPT Editorial Panel PLA code applications for proprietary laboratory-developed tests. The PLA code application process, while more mechanical than an LCD proceeding, requires careful attention to code descriptor language, test characterization, and coordination with the AMA's submission protocols. We have successfully obtained PLA codes for multiple proprietary molecular diagnostic tests and understand the submission timelines, panel review procedures, and code descriptor conventions that maximize the likelihood of approval at the first panel meeting.
LCD Experience with Cascade Fiscal Intermediaries (Jurisdiction E)
Given that GDT's reference laboratory is located in San Diego, California, the relevant MAC for purposes of OncoPrecise GXP-47 is Cascade Fiscal Intermediaries, LLC ("CFI"), which administers Medicare Part B claims for Jurisdiction E, covering California. Our team has navigated the LCD process with CFI on multiple prior occasions, and we are familiar with CFI's submission requirements, the Medical Director's office, and the LCD analysts responsible for genomic diagnostics within Jurisdiction E. This institutional familiarity is a meaningful advantage in an LCD proceeding, where early and productive engagement with the MAC's review team can significantly influence both the pace and outcome of the coverage determination.
CED and NCD Experience
Additionally, our team has experience with CMS's Coverage with Evidence Development ("CED") framework, which may be relevant to GDT's longer-term national coverage strategy, as well as with the traditional NCD process. The CED framework allows CMS to extend Medicare coverage for a test or service conditioned on the test's use within the context of an approved clinical study or registry, and it may offer a pathway for OncoPrecise GXP-47 if the clinical evidence base supports an early NCD filing before the full body of post-market data has matured.
Venture-Backed and PE-Backed Company Experience
Finally, we recognize that GDT is a venture-backed company at a critical inflection point in its growth trajectory. Our team has extensive experience advising venture-backed and private equity-backed biotechnology and diagnostics companies on reimbursement strategy in connection with commercialization planning. We understand the dynamics that govern these engagements — the role of reimbursement milestones in investor reporting and financing timelines, the importance of board-level communication on regulatory progress, and the need to calibrate legal strategy to the company's capital resources and commercialization timeline.
III. Understanding of GDT and OncoPrecise GXP-47
A successful coverage and coding engagement requires a thorough understanding of the company, the test at issue, the clinical context, and the evidentiary record. Below, we summarize our current understanding of GDT and OncoPrecise GXP-47, based on the materials provided with the RFP and publicly available information. We expect to refine and deepen this understanding during the engagement kickoff process.
Company Background. Genome Dx Therapeutics Inc. is a Delaware corporation headquartered in San Diego, California. GDT is a clinical-stage molecular diagnostics company specializing in the development and commercialization of next-generation sequencing-based genomic tests for oncology applications. The Company was founded in 2018 by Dr. Anisha Raval and Dr. Marcus Yuen, and its operations are centered on a single CLIA-certified, CAP-accredited reference laboratory located at the Company's San Diego headquarters.
The laboratory's key regulatory credentials include:
• CLIA Certificate Number: 05D2187432
• CAP Accreditation Number: 9074821
• National Provider Identifier (NPI): 1902847365
GDT's existing commercial product is OncoPrecise GXP-12, a 12-gene expression panel used in early-stage breast cancer prognosis. OncoPrecise GXP-12 is currently reimbursed under an existing local coverage determination — specifically, LCD L38472, effective August 15, 2021, issued by Cascade Fiscal Intermediaries. GDT's fiscal year 2023 revenue of approximately $6.2 million was derived entirely from OncoPrecise GXP-12, which underscores both the company's existing relationship with CFI and the importance of the LCD pathway to GDT's commercial model.
From a capital perspective, GDT has raised approximately $187 million across its Series A through Series C financing rounds. The most recent round, a Series C financing of $78 million, was led by Pinnacle Health Ventures, L.P. ("PHV") and closed on March 28, 2022. PHV currently holds approximately 41.3% of GDT's fully diluted equity, making it the Company's largest institutional investor. We are mindful that PHV's governance role and reporting expectations will likely inform the cadence and level of detail of board-level communications regarding the coverage strategy.
GDT's intellectual property portfolio includes fourteen issued U.S. patents and seven pending patent applications related to the OncoPrecise platform. While intellectual property strategy falls outside the scope of this engagement, the existence of a robust patent portfolio is a relevant consideration in the PLA code application process, as the AMA CPT Editorial Panel expects PLA codes to be associated with proprietary, single-source tests.
OncoPrecise GXP-47 Test Description
OncoPrecise GXP-47 is a laboratory-developed test ("LDT") performed exclusively at GDT's San Diego reference laboratory. As we understand it, the test is designed as follows:
Specimen Type and Processing. OncoPrecise GXP-47 analyzes RNA extracted from formalin-fixed, paraffin-embedded ("FFPE") NSCLC tumor tissue specimens. The use of FFPE specimens is consistent with standard oncology pathology workflows and avoids the need for fresh or frozen tissue, which is a meaningful practical advantage in the clinical setting.
Gene Panel Composition. The test interrogates the expression levels of forty-seven genes using a proprietary NGS-based RNA sequencing methodology. The selection of the 47-gene panel reflects GDT's proprietary gene expression research, and the panel is designed to capture the key signaling pathways and immune microenvironment features that are predictive of response to immune checkpoint inhibitor therapy in NSCLC.
Therapy Response Index (TRI) Score. The assay output is a composite Therapy Response Index ("TRI") score, derived from a proprietary algorithmic analysis of the 47-gene expression data. The TRI score ranges from 0 to 100 and stratifies patients into three clinically actionable categories:
• High Likelihood of Response — TRI score ≥ 70: patients in this category are predicted to derive meaningful clinical benefit from first-line immune checkpoint inhibitor ("ICI") therapy;
• Intermediate — TRI score 40 to 69: patients in this category have an uncertain predicted response, and the test result should be considered alongside other clinical and pathological factors in treatment planning; and
• Low Likelihood of Response — TRI score < 40: patients in this category are predicted to have a low probability of response to ICI therapy and may be better served by alternative first-line treatment strategies, such as platinum-based chemotherapy.
Intended Clinical Use. The intended clinical use of OncoPrecise GXP-47 is to guide oncologist decision-making regarding whether to initiate first-line immune checkpoint inhibitor therapy (including, for example, pembrolizumab, nivolumab, or atezolizumab) versus platinum-based chemotherapy in patients with Stage IIIB or Stage IV NSCLC. This is a clinical decision of enormous consequence — ICI therapy has transformed outcomes for a subset of advanced NSCLC patients, but response rates remain variable, and patients who do not respond to ICI therapy may experience disease progression during a period when they could have been receiving an effective alternative treatment. A validated predictive biomarker that identifies likely responders and non-responders would thus address a significant unmet clinical need and could generate meaningful health economic value by directing costly ICI therapy to the patients most likely to benefit.
Analytical Validation. GDT completed analytical validation of OncoPrecise GXP-47 on December 14, 2022. The results of the analytical validation study were published in the Journal of Molecular Oncology Diagnostics, Volume 18, Issue 4, pages 412–429, December 2022. The publication of analytical validation results in a peer-reviewed journal is an important element of the evidentiary foundation for the MolDx technical assessment dossier, as Ridgeline's review team places significant weight on peer-reviewed data.
CLARITY-LUNG Clinical Validation Study
The centerpiece of GDT's clinical evidence program for OncoPrecise GXP-47 is the CLARITY-LUNG study — a prospective, multi-site, blinded clinical validation study designed to assess the predictive performance of the TRI score in a real-world patient population.
Key details of the CLARITY-LUNG study are as follows:
• Registration. ClinicalTrials.gov Identifier: NCT05891247
• Study Design. Prospective, multi-site, blinded clinical validation study
• Number of Clinical Sites. Fourteen clinical sites across the United States
• Enrollment Target. 1,200 patients with newly diagnosed Stage IIIB or Stage IV NSCLC
• Enrollment Commencement. January 18, 2023
• Principal Investigator. Dr. Priya Sundaram, Vice President of Clinical Development, GDT
• Data Safety Monitoring Board (DSMB) Chair. Dr. Evelyn Matsuda, MD, PhD, Carrington Cancer Institute, Houston, Texas
• Primary Endpoint. Positive predictive value ("PPV") and negative predictive value ("NPV") of TRI score for twelve-month progression-free survival ("PFS") on ICI therapy
• Total Trial Budget. $28.5 million
• Projected Final Data Readout. Originally projected for the fourth quarter of 2024
We note that, as of the date of this proposal, interim analysis results from CLARITY-LUNG are not yet available. This is a significant consideration for the engagement timeline, because the strength and substance of the clinical validation data will be a critical determinant of the LCD strategy, the content of the MolDx technical assessment dossier, and the reimbursement rate justification. Our proposed strategy and timeline, described below, are designed to be calibrated and adjusted as clinical data becomes available. We anticipate working closely with Dr. Sundaram and GDT's clinical development team to integrate clinical data into the coverage strategy on a rolling basis as interim and final results emerge.
IV. Proposed Scope of Work
We propose to organize the engagement around five integrated workstreams, each designed to address a discrete but interrelated component of the overall Medicare coverage and coding strategy for OncoPrecise GXP-47. The workstreams are intended to proceed in a sequenced and overlapping manner, as described in the proposed timeline in Section VII below.
Workstream 1: Coding Strategy and PLA Code Application
The first critical milestone in the coverage and reimbursement pathway is securing the appropriate procedural code for OncoPrecise GXP-47. The coding decision is foundational — it determines how the test is identified in the Medicare claims system, influences the reimbursement rate methodology, and shapes payer perceptions of the test's clinical and economic profile.
Coding Analysis. We will conduct a comprehensive analysis of the coding options available for OncoPrecise GXP-47. The two principal alternatives are: (a) a Proprietary Laboratory Analyses ("PLA") code, which would be a unique code assigned exclusively to OncoPrecise GXP-47 and recognizing its proprietary nature and single-source availability; and (b) existing CPT codes for NGS-based genomic analyses, most notably CPT 81455 (next-generation sequencing, solid organ neoplasm, 51 or more genes, interrogation for somatic mutations, including copy number variants if performed, and microsatellite instability), or potentially other existing Tier 2 molecular pathology codes. The analysis will evaluate the trade-offs between these options across several dimensions, including reimbursement rate implications, payer recognition and claims adjudication dynamics, the long-term commercial positioning of the test, and the practical relationship between coding and the LCD and reimbursement rate proceedings.
Coding Recommendation. Based on our preliminary assessment, we anticipate recommending a PLA code application as the optimal pathway. The proprietary TRI algorithm, the single-source LDT model, and GDT's premium reimbursement positioning objectives all point toward a dedicated PLA code as the best strategic choice. However, this recommendation will be fully analyzed and documented in the Coding Strategy Memorandum delivered in Workstream 1, and we will discuss the analysis with GDT's team before finalizing the recommendation.
PLA Code Application Preparation and Filing. Upon GDT's approval of the coding strategy, we will prepare and file the PLA code application with the AMA CPT Editorial Panel. This will include drafting the proposed PLA code descriptor — the succinct clinical and technical description of the test that will appear in the CPT code set — as well as preparing the supporting documentation required by the AMA's submission guidelines. We will coordinate with GDT's coding and billing consultant on the application mechanics, as we understand that GDT has retained (or intends to retain) a specialized coding firm for this purpose. Calderwood & Harkness will lead on the strategic dimensions of the PLA code application, including the descriptor language, the clinical rationale, and the positioning of the application for panel review, while the coding consultant will assist with formatting, AMA submission protocols, and other administrative aspects.
Target Submission. The AMA CPT Editorial Panel conducts its PLA code review at regular intervals, and we have identified the Panel's September 2024 meeting as the target for OncoPrecise GXP-47's PLA code consideration. The submission deadline for that meeting is June 28, 2024. We will work backward from that deadline to ensure that the application is prepared, reviewed, and finalized with sufficient lead time.
Deliverables for Workstream 1:
1. Coding Strategy Memorandum — A detailed analysis of coding options (PLA versus existing CPT codes) with a recommended pathway, risk assessment, and implementation plan.
2. Draft PLA Code Application — A complete draft of the PLA code application package, including proposed code descriptor, supporting clinical and technical documentation, and cover letter.
3. Cover Letter to AMA CPT Editorial Panel — A formal transmittal letter for the PLA code application submission.
Workstream 2: LCD Application and MolDx Technical Assessment
The local coverage determination is the gateway to Medicare reimbursement for OncoPrecise GXP-47. Obtaining a favorable LCD from CFI, supported by a successful MolDx technical assessment, is the single most consequential milestone in the engagement.
LCD Request Strategy. We will develop a comprehensive LCD request strategy for submission to Cascade Fiscal Intermediaries, LLC, the MAC for Jurisdiction E, which covers California and is the jurisdictional MAC for GDT's reference laboratory. The strategy will address the framing of the LCD request, the clinical indication and patient population for which coverage is sought, the evidentiary standard that CFI and Ridgeline will apply to the request, and the sequencing of the LCD request relative to the PLA code application and the availability of CLARITY-LUNG data.
LCD Request Letter. We will prepare a formal LCD request letter addressed to CFI's Medical Director, Dr. William Hargrove, and LCD Analyst for genomic diagnostics, Sandra Phu. The LCD request letter is the initial submission that triggers the MAC's coverage review process, and it must clearly and persuasively articulate the clinical rationale for coverage, the target patient population, the evidentiary basis for the request, and the regulatory and quality credentials of the testing laboratory.
MolDx Technical Assessment Dossier. The MolDx technical assessment dossier is the comprehensive evidentiary submission that will be reviewed by Ridgeline Administrative Services, LLC, the MolDx program administrator located in Columbia, South Carolina. The dossier is reviewed by Ridgeline's technical assessment team under the direction of Dr. Catherine Embry, the MolDx Technical Assessment Director, and the outcome of that review is the principal input into CFI's coverage determination. We will prepare the MolDx dossier in accordance with the MolDx program's technical assessment framework and will structure it to include the following elements:
(1) Test Description and Intended Use — A detailed description of OncoPrecise GXP-47, including specimen type, gene panel composition, analytical methodology, TRI scoring algorithm, and intended clinical application, tailored to the MolDx program's format and disclosure requirements.
(2) Analytical Validation Data — A summary and analysis of the analytical validation study completed December 14, 2022, with reference to the published results in the Journal of Molecular Oncology Diagnostics and any additional analytical validation data generated since publication.
(3) Clinical Validation Data — Presentation and analysis of clinical validation data, principally from the CLARITY-LUNG study and any other available clinical studies, demonstrating the predictive accuracy of the TRI score for the primary endpoint (PPV and NPV for 12-month PFS on ICI therapy).
(4) Clinical Utility Evidence — Evidence demonstrating that the use of OncoPrecise GXP-47 in clinical practice leads to improved patient outcomes or changes in clinical management that result in measurable health benefits. This section will draw upon GDT's HEOR consultant's work product, as described below.
(5) Health Economic Analysis — An analysis of the cost-effectiveness and budget impact of OncoPrecise GXP-47, demonstrating that the test generates economic value for the Medicare program by directing ICI therapy to patients most likely to benefit and avoiding ineffective treatment in non-responders. As discussed in Section VI, we understand that GDT intends to retain an independent HEOR consultant to prepare the clinical utility and cost-effectiveness analyses; Calderwood & Harkness will review the HEOR work product for regulatory compliance and strategic alignment with the MolDx submission framework.
(6) Annotated Bibliography — A comprehensive, annotated bibliography of peer-reviewed supporting publications, including publications on the 47-gene panel, the TRI algorithm, the CLARITY-LUNG study, and relevant clinical literature on ICI therapy prediction in NSCLC.
HEOR Integration. We understand that GDT intends to retain an independent health economics and outcomes research ("HEOR") consultant to prepare the clinical utility and cost-effectiveness analyses that will be incorporated into the MolDx dossier. Calderwood & Harkness will review and mark up the HEOR consultant's work product to ensure that it is presented in a manner that satisfies MolDx program requirements, is consistent with the overall coverage narrative, and is strategically aligned with the arguments we advance in the LCD request. We will not prepare the underlying health economic models, as this is appropriately within the scope of the HEOR consultant's mandate.
Target LCD Filing. We have identified August 2024 as the target date for filing the LCD request with CFI and submitting the MolDx dossier to Ridgeline. This target is contingent on two prerequisites: (a) assignment of a PLA code (or, at minimum, filing of the PLA code application) prior to LCD submission; and (b) availability of sufficient clinical validation data from the CLARITY-LUNG study to support the dossier's clinical validation and clinical utility sections. We will monitor the progress of both prerequisites and adjust the filing timeline as necessary in consultation with GDT's team.
Deliverables for Workstream 2:
1. LCD Regulatory Landscape Memorandum — An analysis of the LCD regulatory landscape for NGS-based oncology diagnostics within Jurisdiction E, including a review of existing CFI LCDs, relevant MolDx precedent, and an assessment of the evidentiary bar for coverage.
2. Draft LCD Request Letter — A formal LCD request letter to CFI's Medical Director and LCD Analyst, suitable for submission upon GDT's approval.
3. Draft MolDx Technical Assessment Dossier — A comprehensive MolDx dossier structured in accordance with Ridgeline's technical assessment requirements, incorporating all six evidentiary components described above.
4. Review and Mark-Up of HEOR Analysis — Marked-up version of the HEOR consultant's clinical utility and cost-effectiveness analyses, with recommendations for revisions to ensure regulatory compliance and strategic alignment.
Workstream 3: Reimbursement Rate Analysis
Securing the right reimbursement rate is essential to the commercial viability of OncoPrecise GXP-47. The Medicare reimbursement rate will serve as the benchmark against which commercial payer rates are negotiated and will directly impact GDT's revenue projections and financial model.
Crosswalk and Gapfill Analysis. Under the Protecting Access to Medicare Act ("PAMA") and CMS's implementing regulations, the reimbursement rate for a new clinical laboratory test may be established through a crosswalk to an existing test on the Clinical Laboratory Fee Schedule or through a gapfill process administered by the MACs. We will conduct a thorough analysis of both methodologies as applied to OncoPrecise GXP-47.
Comparable Code Analysis. We will identify and analyze comparable PLA and CPT codes for NGS-based oncology diagnostic panels, including currently listed codes for multi-gene expression assays in lung cancer and other solid tumors. This analysis will establish the range of existing reimbursement rates for tests with analogous analytical characteristics and clinical applications, and will provide the foundation for GDT's pricing justification.
Pricing Justification Strategy. A central element of the reimbursement rate analysis will be the development of a pricing justification strategy that supports a premium reimbursement rate relative to generic NGS codes. The proprietary TRI algorithm, the extensive clinical validation program (including the CLARITY-LUNG trial), the clinical utility of the predictive score, and the health economic value of the test are all factors that can support a premium pricing position. We will develop a cohesive narrative and supporting analysis that articulates why OncoPrecise GXP-47 warrants a reimbursement rate above that of comparable generic panels.
Revenue Projection Support. In addition to the rate analysis itself, we will review the reimbursement assumptions underlying GDT's financial models, including the assumed Medicare mix, commercial payer rates, volume projections, and reimbursement rate estimates. This review is intended to ensure that GDT's financial projections are grounded in realistic reimbursement rate expectations and are defensible in the context of investor reporting and board-level discussions. We note that this support does not constitute financial advisory work and is limited to the reimbursement rate assumptions within our area of expertise.
Deliverables for Workstream 3:
1. Reimbursement Rate Analysis Memorandum — A detailed analysis of the crosswalk and gapfill pricing methodologies as applied to OncoPrecise GXP-47, with recommended rate targets and pricing justification strategy.
2. Crosswalk/Gapfill Pricing Model (Excel) — A working pricing model identifying comparable codes, their reimbursement rates, and the basis for GDT's proposed rate, in Excel format for integration with GDT's financial models.
Workstream 4: NCD Pathway Assessment
While the LCD represents the near-term priority, GDT's long-term Medicare coverage strategy should contemplate the possibility — and the potential strategic advantages — of pursuing a national coverage determination through CMS. An NCD would establish Medicare coverage for OncoPrecise GXP-47 on a nationwide basis, eliminating the need to obtain LCDs from multiple MACs and providing the most comprehensive and durable form of Medicare coverage.
NCD Feasibility Analysis. We will assess the feasibility and timeline for pursuing an NCD for OncoPrecise GXP-47, taking into account the current CMS NCD landscape for genomic diagnostics, the evidentiary standards applicable to NCD proceedings, the resource requirements of an NCD submission, and the expected timeline for CMS review and decision.
NCD Pathway Analysis. We will analyze the two principal NCD pathways: (a) the traditional NCD process, in which CMS conducts an internal coverage analysis and issues a proposed and final NCD; and (b) the Coverage with Evidence Development ("CED") framework, under which CMS may extend conditional coverage while additional evidence is generated through approved clinical studies or registries. We will assess which pathway (or combination of pathways) is most appropriate for OncoPrecise GXP-47 given the maturity of the clinical evidence base and GDT's commercialization timeline.
Sequencing Recommendations. A key strategic question is whether GDT should pursue the LCD first and defer the NCD to a later stage, or whether there are advantages to initiating the NCD process on a parallel track with the LCD. We will provide specific recommendations on sequencing, informed by our experience with the interaction between LCD and NCD proceedings and the practical resource implications for GDT.
Deliverable for Workstream 4:
1. NCD Feasibility Assessment Memorandum — A comprehensive assessment of NCD feasibility, pathway options, sequencing recommendations, timeline estimates, and resource implications.
Workstream 5: Ongoing Advisory and Board Support
The Medicare coverage and coding process is dynamic and extends well beyond the initial filings. We propose to provide GDT with ongoing strategic advisory support throughout the engagement, including the following:
Board Presentations. We will attend and prepare materials for GDT board presentations on coverage and reimbursement strategy. Given the significance of the OncoPrecise GXP-47 coverage strategy to GDT's commercialization plan and the interests of PHV and other institutional investors, we anticipate that the board will require periodic updates on the progress of the coding, LCD, and reimbursement rate workstreams. We will prepare presentation-quality materials (slide decks, memoranda, or other formats as directed) for these purposes.
Coordination with Outside Counsel. GDT retains separate outside counsel for corporate, intellectual property, and other matters. We will coordinate with GDT's regular outside counsel as needed on regulatory-related board presentations, corporate-level decisions that intersect with the coverage strategy, and other matters requiring cross-functional communication.
CMS Policy Monitoring. We will monitor CMS policy developments, MolDx program updates, and LCD and NCD precedent relevant to NGS-based oncology diagnostics on an ongoing basis throughout the engagement. The regulatory environment for molecular diagnostics is highly dynamic — CMS and the MolDx program regularly issue guidance, revise LCD criteria, and adjust program requirements — and GDT's coverage strategy must remain responsive to these developments.
Commercial and Financial Implications. As requested by GDT, we will assess the downstream commercial and financial implications of coverage outcomes, including the potential impact on lending covenants, investor reporting obligations, and strategic planning. This advisory function is intended to supplement, not replace, the work of GDT's financial advisors and is limited to the reimbursement-specific aspects within our area of expertise.
V. Proposed Engagement Team
We have assembled a team that combines deep Medicare coverage and reimbursement expertise, direct CMS institutional experience, health technology assessment knowledge, and hands-on coding and billing compliance skills. Each member of the proposed team has been selected for a specific role, and the team is structured to ensure efficient and cost-effective execution of the engagement.
Miriam Calloway — Partner (Responsible Partner)
Miriam Calloway will serve as the Responsible Partner for the engagement, providing overall strategic direction and serving as GDT's primary relationship partner. Ms. Calloway is based in Calderwood & Harkness's Washington, D.C. office at 1700 K Street NW, Suite 900, Washington, DC 20006.
Ms. Calloway has twenty-eight years of experience in Medicare coverage and reimbursement law, with a concentrated focus on molecular diagnostics and genomic testing over the past fifteen years. She has been personally involved in more than fifteen LCD and NCD proceedings before MACs and CMS, representing a range of molecular diagnostics companies from early-stage ventures to publicly traded reference laboratories. Her representative engagements have included LCD proceedings for multi-gene expression panels in oncology, pharmacogenomic testing platforms, and liquid biopsy assays, as well as NCD proceedings under both the traditional and CED frameworks. Ms. Calloway is a recognized authority in the Medicare coverage space for molecular diagnostics and is regularly invited to speak at industry conferences on coverage strategy, MolDx program developments, and CMS policy.
In her capacity as Responsible Partner, Ms. Calloway will lead the overall strategic direction of the engagement, serve as the primary point of contact for GDT's leadership team, lead client presentations and board meetings, direct the LCD and NCD strategy, and provide senior review of all major deliverables.
Proposed Hourly Rate: $1,350
Joel Strauss — Partner (Billing Partner)
Joel Strauss will serve as the Billing Partner and will provide strategic counsel on the NCD pathway assessment, health technology assessment components of the MolDx dossier, and the intersection of FDA regulatory considerations with CMS coverage requirements. Mr. Strauss is based in Calderwood & Harkness's San Francisco office at 555 California Street, Suite 3200, San Francisco, CA 94104.
Mr. Strauss specializes in health technology assessment and the intersection of FDA and CMS regulatory frameworks. His practice focuses on the evidentiary and analytical standards that govern coverage decisions for new technologies, and he has particular expertise in the CMS NCD process and the Coverage with Evidence Development framework. His proximity to GDT's California operations provides an additional benefit in terms of accessibility and coordination.
In his capacity as Billing Partner, Mr. Strauss will oversee billing and financial aspects of the engagement, provide strategic counsel on the NCD feasibility assessment (Workstream 4), contribute to the health technology assessment components of the MolDx dossier, and advise on FDA/CMS regulatory intersections.
Proposed Hourly Rate: $1,275
Sean Morrissey — Senior Associate (Lead Associate)
Sean Morrissey will serve as the Lead Associate and day-to-day project manager for the engagement. Mr. Morrissey is based in Calderwood & Harkness's Washington, D.C. office.
Mr. Morrissey has six years of experience in healthcare regulatory law, with a focus on CMS coverage and reimbursement proceedings for diagnostic and therapeutic technologies. Critically, prior to entering private practice, Mr. Morrissey served as a policy analyst at CMS's Coverage and Analysis Group ("CAG"), the division within CMS responsible for conducting national coverage analyses and supporting the Medicare Coverage Advisory Committee. Mr. Morrissey's tenure at CAG provides him with direct, first-hand experience with CMS's internal coverage review processes, the analytical frameworks applied by CMS reviewers, the types and quality of evidence that CMS finds persuasive, and the institutional dynamics that influence coverage decisions. This insider perspective is an invaluable asset for any engagement involving CMS coverage proceedings.
In his capacity as Lead Associate, Mr. Morrissey will serve as the day-to-day lead on the LCD and MolDx workstream, manage the preparation of the MolDx technical assessment dossier, lead the analysis of clinical evidence for coverage purposes, coordinate with GDT's clinical development team (including Dr. Sundaram), and serve as the primary day-to-day point of contact for GDT's coverage and reimbursement team.
Proposed Hourly Rate: $875
Christopher Aiken — Associate (Working Associate)
Christopher Aiken will serve as the Working Associate, with primary responsibility for the coding and reimbursement rate workstreams. Mr. Aiken is based in Calderwood & Harkness's San Francisco office.
Mr. Aiken has three years of experience in healthcare regulatory law, with a focused practice in CPT and HCPCS coding and laboratory billing compliance. He has experience preparing PLA code applications and crosswalk/gapfill pricing analyses for molecular diagnostic tests and is familiar with the AMA CPT Editorial Panel's submission requirements and review procedures. Mr. Aiken will coordinate directly with GDT's coding and billing consultant on application mechanics and formatting.
In his capacity as Working Associate, Mr. Aiken will lead the preparation of the PLA code application (Workstream 1), conduct the crosswalk/gapfill reimbursement rate analysis (Workstream 3), coordinate with GDT's coding and billing consultant, and support the MolDx dossier preparation as needed.
Proposed Hourly Rate: $650
Paralegal Support. The engagement team will be supported by dedicated paralegal resources from Calderwood & Harkness's Healthcare & Life Sciences practice group. Paralegals will provide document preparation, annotated bibliography compilation, regulatory filing logistics, cite-checking and source verification, and general research support throughout the engagement.
Proposed Hourly Rate: $375
VI. Coordination with GDT's Other Advisors
We recognize that an engagement of this nature does not occur in isolation — GDT's Medicare coverage and coding strategy must be developed in coordination with a number of other advisors and consultants whose work product will interface with the engagement. Effective coordination among advisors is essential to avoiding duplication of effort, ensuring strategic alignment, and delivering an integrated coverage strategy.
Based on the information provided in the RFP, we understand that GDT retains (or intends to retain) the following additional advisors:
Coding and Billing Consultant. GDT has retained or intends to retain a specialized coding and billing consultant to assist with PLA code application mechanics, crosswalk/gapfill pricing submission support, and ongoing coding and billing compliance. Calderwood & Harkness will lead on the strategic dimensions of the coding strategy — including the PLA versus CPT analysis, the code descriptor language, and the positioning of the application — while the coding consultant will assist with formatting, AMA submission protocols, and other administrative and technical aspects of the application process. We expect to work collaboratively with the coding consultant, with clear delineation of responsibilities.
HEOR Consultant. GDT intends to retain an independent health economics and outcomes research consultant to prepare the clinical utility and cost-effectiveness analyses that will be incorporated into the MolDx technical assessment dossier. This is an appropriate scope delineation — the preparation of health economic models, budget impact analyses, and clinical utility assessments requires specialized HEOR expertise, and these analyses are best prepared by a dedicated HEOR firm with experience in the MolDx context. Calderwood & Harkness will review the HEOR consultant's work product for regulatory compliance and strategic alignment with the MolDx submission framework, provide feedback and mark-ups to ensure that the HEOR analyses are presented in a manner consistent with MolDx program requirements, and integrate the HEOR analyses into the overall dossier narrative. We will not prepare the underlying health economic models.
Regular Outside Counsel (Corporate/IP). GDT retains separate outside counsel for corporate governance, board matters, intellectual property, securities, and other non-coverage-related legal matters. Calderwood & Harkness's engagement is limited to Medicare coverage and coding strategy for OncoPrecise GXP-47, and we will coordinate with GDT's regular outside counsel as needed on regulatory-related board presentations, corporate-level decisions that intersect with the coverage strategy, and other matters requiring cross-functional communication.
Financial Advisor / Investment Bank. GDT may retain a financial advisor or investment bank for financial modeling and other purposes. To the extent that GDT's financial models incorporate reimbursement rate assumptions, Calderwood & Harkness will provide reimbursement rate inputs based on our Workstream 3 analysis. We will not perform financial advisory work.
Calderwood & Harkness's work will be carefully scoped to avoid duplication with these other advisors' mandates. We will establish clear responsibility delineation at the outset of the engagement and maintain regular coordination throughout.
The primary day-to-day coordination points for the engagement will be:
• Theresa Nakamura, General Counsel & Vice President of Regulatory Affairs — for legal, regulatory, and strategic matters; and
• Kevin Driscoll, Vice President of Market Access & Reimbursement — for reimbursement strategy, coding, and payer-related matters.
We welcome the opportunity to discuss the coordination framework in greater detail during the engagement kickoff process and are flexible in adapting our approach to GDT's preferred communication and project management structures.
VII. Proposed Timeline
The following table sets forth our proposed timeline for the engagement, organized by milestone. We emphasize that this timeline is contingent on two key external factors: (a) the availability of clinical validation data from the CLARITY-LUNG trial, and (b) GDT's commercialization schedule. We will revisit and adjust the timeline as necessary in coordination with GDT's team.
Note: The timeline above represents our current best estimate based on available information. All dates are subject to adjustment based on the progress of the CLARITY-LUNG trial, AMA CPT Editorial Panel scheduling, MAC processing timelines, and GDT's commercialization decisions. We will provide regular timeline updates and will flag any material changes to the projected schedule as soon as they become apparent.
VIII. Fee Estimate and Billing Arrangements
Fee Arrangement. Calderwood & Harkness proposes to bill for this engagement on an hourly basis at the following rates:
These rates are the firm's standard rates for the proposed timekeepers as of the date of this proposal and are subject to annual adjustment in accordance with the firm's standard rate review process. Any rate adjustments would be communicated to GDT in advance.
Budgeted Fee Estimate
Based on our assessment of the scope of work described in Section IV and our experience with engagements of comparable scale and complexity, we estimate that the total professional fees for the full scope of work through LCD issuance will fall in the range of $475,000 to $575,000. This estimate is broken down by workstream as follows:
Workstream 1 — Coding Strategy & PLA Code Application. This workstream involves a discrete set of deliverables (Coding Strategy Memorandum, PLA Code Application, Cover Letter) and is expected to represent a moderate portion of the overall budget. The work is concentrated in the first four months of the engagement and is driven primarily by associate-level effort with partner review.
Workstream 2 — LCD Application & MolDx Technical Assessment. This workstream is the largest component of the engagement by both hours and complexity. The preparation of the MolDx technical assessment dossier is a labor-intensive process that requires extensive clinical evidence analysis, narrative drafting, bibliography compilation, and multiple rounds of internal and client review. This workstream will account for the single largest share of the budgeted fees.
Workstream 3 — Reimbursement Rate Analysis. The crosswalk/gapfill analysis and pricing justification strategy represent a moderate allocation of effort, involving both associate-level analytical work and partner-level strategic review.
Workstream 4 — NCD Pathway Assessment. At this stage, Workstream 4 is limited to a preliminary feasibility assessment and represents a smaller allocation. If GDT subsequently determines to pursue an NCD, the scope and budget for NCD proceedings would be separately estimated at that time.
Workstream 5 — Ongoing Advisory & Board Support. The ongoing advisory workstream is variable by nature and will depend on the frequency and scope of board presentations, the pace of CMS policy developments, and GDT's ad hoc advisory needs.
Important Notes Regarding the Fee Estimate:
• The budgeted estimate of $475,000 to $575,000 does not include fees for NCD proceedings if pursued. If GDT decides to initiate an NCD process following LCD issuance, we will provide a separate scope and fee estimate for that phase of the engagement.
• The estimate assumes the timely cooperation of GDT's other advisors, including the coding and billing consultant and the HEOR consultant, in providing their respective work products on schedule. Delays in the availability of HEOR data or coding inputs could increase the total hours required for Calderwood & Harkness's workstreams.
• The fee estimate is not a cap or a fixed fee. Actual fees will depend on the scope and complexity of the work as it unfolds, client-directed changes to the strategy, the volume and complexity of MAC and MolDx program interactions, and other factors outside the firm's control. We will provide regular budget updates and will alert GDT promptly if actual fees are tracking materially above the estimated range.
Disbursements. Disbursements and out-of-pocket expenses will be billed at cost. Typical disbursements for this type of engagement include legal research database charges, printing and copying costs, courier and delivery charges, and travel expenses for in-person meetings, MAC open meetings, or other travel required in connection with the engagement. We will seek GDT's approval before incurring any individual travel expenditure in excess of $2,500.
Billing Cycle and Payment Terms
Calderwood & Harkness will issue invoices on a monthly basis. Each invoice will include a detailed description of the services performed, the timekeeper responsible, the hours expended, and the applicable rate. Payment is due net thirty (30) days from the date of invoice.
IX. Engagement Terms
The following is a summary of the key terms that we propose to govern the engagement. These terms will be set forth in greater detail in a formal engagement letter, which we will prepare and circulate for GDT's review upon acceptance of this proposal.
Scope of Engagement. The engagement is limited to Medicare coverage and coding strategy for OncoPrecise GXP-47 as described in this proposal. Calderwood & Harkness does not serve and will not serve as GDT's general counsel in connection with this engagement.
Excluded Services. Calderwood & Harkness will not provide corporate, intellectual property, securities, tax, or other legal advice outside the defined scope of the engagement. Matters of that nature should be directed to GDT's regular outside counsel or other appropriate advisors.
Conflicts Check. A preliminary conflicts review has been initiated, as described in Section X below. A full formal conflicts check will be completed and documented prior to execution of the engagement letter. The engagement is contingent on satisfactory completion of the conflicts review.
Termination. Either party may terminate the engagement upon written notice to the other party, subject to applicable professional responsibility rules governing withdrawal of counsel. In the event of termination, GDT will be responsible for fees and disbursements incurred through the date of termination.
Client Authority. GDT retains ultimate decision-making authority on all filing and strategy decisions. Calderwood & Harkness will provide recommendations and analysis, but the decision to file, not file, or modify any submission with the AMA, CFI, Ridgeline, CMS, or any other body rests solely with GDT.
Confidentiality. All work product prepared by Calderwood & Harkness in connection with the engagement is for GDT's use and benefit. Calderwood & Harkness will maintain the confidentiality of GDT's information in accordance with the firm's professional obligations and the terms of the engagement letter. We anticipate that the engagement letter will include detailed confidentiality provisions governing the treatment of GDT's proprietary information, clinical data, and business information.
Fee Estimate Disclaimer. The fee estimate set forth in Section VIII is a good-faith estimate based on currently available information and is not a cap on fees. Actual fees will depend on the scope, complexity, and duration of the engagement, the nature and volume of MAC and CMS interactions, client-directed changes to the strategy, and other factors.
X. Conflicts
Calderwood & Harkness has initiated a preliminary conflicts review in connection with this proposal. Based on the results of that preliminary review, the firm is not currently aware of any conflicts of interest that would preclude Calderwood & Harkness from representing GDT in the engagement described herein.
A full formal conflicts check will be completed and documented prior to execution of the engagement letter. The parties and entities to be checked include, without limitation:
• Genome Dx Therapeutics Inc.
• Pinnacle Health Ventures, L.P.
• Cascade Fiscal Intermediaries, LLC