MEMORANDUM
PRIVILEGED & CONFIDENTIAL ATTORNEY WORK PRODUCT
TO: Miriam Calloway, Partner, Healthcare & Life Sciences Practice Group
FROM: Office of the General Counsel, Calderwood & Harkness LLP — New Engagement / Conflicts Review Unit
DATE: February 12, 2024
RE: Conflicts Check Results — Proposed Engagement of Genome Dx Therapeutics Inc. (New Client No. 47832; Matter No. 1043-00002)
MATTER DESCRIPTION: Medicare Coverage and Coding Strategy for OncoPrecise GXP-47 Genomic Diagnostic Test
REQUESTING ATTORNEY: Miriam Calloway, Partner (Washington, D.C. Office)
BILLING PARTNER: Joel Strauss, Partner (San Francisco Office)
FIRM OFFICES INVOLVED:
Washington, D.C. — 1700 K Street NW, Suite 900, Washington, DC 20006
San Francisco — 555 California Street, Suite 3200, San Francisco, CA 94104
I. Purpose and Scope of Conflicts Review
This memorandum documents the results of a comprehensive conflicts of interest check conducted by the New Engagement / Conflicts Review Unit of the Office of the General Counsel of Calderwood & Harkness LLP (the "Firm" or "C&H") in connection with the proposed engagement of Genome Dx Therapeutics Inc. ("GDT") as a new client of the Firm. The purpose of this memorandum is to identify, analyze, and memorialize any actual, potential, or positional conflicts of interest that might arise from the Firm's proposed representation of GDT, and to provide clearance or recommend remedial measures prior to the execution of a formal engagement letter.
This conflicts check was initiated in connection with the Firm's engagement proposal submitted to GDT on February 6, 2024, in response to GDT's January 22, 2024 request for proposals ("RFP") seeking outside counsel to serve as Medicare coverage and coding counsel for its novel multi-gene genomic diagnostic test platform. The engagement proposal was prepared by Miriam Calloway, Partner, in the Firm's Healthcare & Life Sciences Practice Group, with input from Joel Strauss, Partner, in the Firm's San Francisco office.
The scope of the proposed engagement encompasses the development and execution of a comprehensive Medicare coverage and coding strategy for GDT's OncoPrecise GXP-47 genomic diagnostic test. Specifically, the engagement is expected to include, but not be limited to, the following workstreams:
(a) Preparation and submission of a Proprietary Laboratory Analyses ("PLA") code application to the American Medical Association ("AMA") CPT Editorial Panel for the OncoPrecise GXP-47 test;
(b) Development and execution of a Local Coverage Determination ("LCD") and Molecular Diagnostic Services ("MolDx") Program strategy for obtaining Medicare coverage through the applicable Medicare Administrative Contractor ("MAC") and MolDx program administrator;
(c) Assessment of the feasibility and strategic advisability of pursuing a National Coverage Determination ("NCD") pathway through the Centers for Medicare & Medicaid Services ("CMS");
(d) Reimbursement rate analysis, including identification and analysis of crosswalk and gapfill methodologies for establishing an appropriate Medicare reimbursement rate for the OncoPrecise GXP-47 test; and
(e) General regulatory and strategic counsel relating to Medicare coverage and reimbursement for molecular diagnostic tests, as may be reasonably requested by the client during the course of the engagement.
In conducting this review, the Conflicts Review Unit searched the Firm's centralized conflicts database, which encompasses all current and former client representations across all offices of Calderwood & Harkness LLP, all adverse party records associated with such representations, and all personnel affiliation records, including lateral hire portability records and individual attorney conflict disclosures. The database is maintained in accordance with the Firm's Conflicts of Interest Policy (revised January 1, 2024) and the applicable Rules of Professional Conduct governing each jurisdiction in which the Firm maintains offices.
The conflicts check was initiated on February 8, 2024, following receipt of the completed New Business Intake form from the requesting attorney, and was completed on February 12, 2024. The results are set forth in the sections that follow.
II. Identification of Parties Checked
The following parties, entities, and individuals were identified by the requesting attorney and the Conflicts Review Unit as requiring inclusion in the conflicts search. The identification of these parties was based upon information provided in the New Business Intake form, the GDT RFP, publicly available corporate filings, and supplemental inquiries directed to GDT's General Counsel, Theresa Nakamura.
A. Prospective Client and Affiliates
1. Genome Dx Therapeutics Inc.
Also searched as: "GenomeDx," "GDT," "Genome Dx," "Genome Diagnostics Therapeutics"
Entity Type: Corporation (Delaware)
Employer Identification Number (EIN): 83-2947156
Principal Office and Laboratory: 4720 Torrey Pines Road, Suite 300, San Diego, CA 92130
Registered Agent (Delaware): Pemberton Industries, 251 Little Falls Drive, Wilmington, DE 19808
Business Description: GDT is a clinical-stage molecular diagnostics company operating a CLIA-certified (Certificate No. 05D2187432), CAP-accredited (Accreditation No. 9074821) reference laboratory. GDT holds National Provider Identifier ("NPI") No. 1902847365. The company's principal product is the OncoPrecise GXP-47, a multi-gene genomic diagnostic test designed to provide predictive and prognostic information for non-small cell lung cancer ("NSCLC") treatment selection. GDT holds 14 issued United States patents and 7 pending patent applications related to the OncoPrecise platform and its underlying analytical and bioinformatic methodologies.
2. Pinnacle Health Ventures, L.P. ("PHV")
Also searched as: "Pinnacle Health Ventures," "PHV," "Pinnacle Health"
Entity Type: Limited Partnership (Delaware)
Principal Office: 200 Clarendon Street, 48th Floor, Boston, MA 02116
Relationship to GDT: Majority investor holding a 41.3% fully diluted equity stake in GDT. PHV led GDT's $78 million Series C financing round, which closed on March 28, 2022. PHV holds two seats on the GDT Board of Directors, occupied by David Ashford (Managing Partner, PHV) and Elena Marchetti (Partner, PHV).
General Partner: Pinnacle Health Ventures Management, LLC, a Delaware limited liability company with the same principal office address.
3. Westbrook Life Sciences Fund, L.P.
Also searched as: "Westbrook Life Sciences," "Westbrook Fund," "WLSF"
Entity Type: Limited Partnership (Delaware)
Relationship to GDT: Series B investor in GDT. Westbrook Life Sciences Fund, L.P. holds one board representative seat on the GDT Board of Directors, occupied by Reginald Odom.
B. Key Client Personnel and Board Members
The following individuals were identified as key personnel and board members of GDT and were included in the conflicts search. Each individual was searched by full legal name, known aliases, and organizational affiliations.
Dr. Anisha Raval — Co-Founder & Chief Executive Officer; Chair of the Board of Directors
Dr. Marcus Yuen — Co-Founder & Chief Scientific Officer; Member of the Board of Directors
Theresa Nakamura — General Counsel & Vice President of Regulatory Affairs (identified as the primary client contact for the proposed engagement)
Kevin Driscoll — Vice President of Market Access & Reimbursement (identified as the day-to-day engagement contact for operational matters)
Dr. Priya Sundaram — Vice President of Clinical Development; Principal Investigator of the CLARITY-LUNG clinical validation trial (ClinicalTrials.gov Identifier: NCT05891247)
Raymond Ota — Chief Financial Officer
David Ashford — Managing Partner, Pinnacle Health Ventures, L.P.; Member of the GDT Board of Directors
Elena Marchetti — Partner, Pinnacle Health Ventures, L.P.; Member of the GDT Board of Directors
Dr. Franklin Mosley — Independent Director of GDT (former Chief Medical Officer of Harborview Diagnostics, Inc.)
Catherine Hwang — Independent Director of GDT (former Chief Financial Officer of Altius Biosciences, Inc.)
Reginald Odom — Member of the GDT Board of Directors; representative of Westbrook Life Sciences Fund, L.P.
C. Adverse and Interested Parties / Government Entities
The following entities and individuals were identified as potentially adverse or interested parties in connection with the proposed engagement. Given the nature of the engagement — which involves regulatory strategy and submissions to government agencies and government contractors — the characterization of these parties as "adverse" is used in a broad sense consistent with the Firm's conflicts policies and does not necessarily connote a traditional adversarial relationship.
1. Cascade Fiscal Intermediaries, LLC ("CFI")
Also searched as: "Cascade Fiscal," "CFI," "Cascade Intermediaries"
Entity Type: Limited Liability Company (Oregon)
Principal Office: 2800 SW Moody Avenue, Suite 500, Portland, OR 97201
Relationship to Engagement: CFI is the Medicare Administrative Contractor ("MAC") for Jurisdiction E (California), the jurisdiction in which GDT's CLIA-certified laboratory is located and from which GDT will submit Medicare claims for the OncoPrecise GXP-47 test. CFI will be the primary MAC with which GDT must interact for purposes of obtaining local Medicare coverage for the test.
Key Personnel Checked:
• Dr. William Hargrove — Medical Director, Molecular Diagnostics Coverage
• Sandra Phu — LCD Analyst, Genomic Diagnostics
Note: CFI operates as a government contractor under contract with CMS for the administration of Medicare Part B claims and coverage determinations. CFI is not a traditional adverse party in the litigation sense; however, CFI was checked for any current or recent representation by the Firm that could give rise to a conflict or the appearance of a conflict.
2. Ridgeline Administrative Services, LLC ("RAS")
Also searched as: "Ridgeline Administrative," "RAS," "Ridgeline Services"
Entity Type: Limited Liability Company (South Carolina)
Principal Office: 1600 Hampton Street, Suite 700, Columbia, SC 29201
Relationship to Engagement: RAS is the administrator of the Molecular Diagnostic Services ("MolDx") Program, a CMS-contracted program that conducts technical assessments of molecular diagnostic tests to support MAC coverage determinations. GDT's OncoPrecise GXP-47 test will be subject to MolDx technical assessment as part of the LCD coverage strategy.
Key Personnel Checked:
• Dr. Catherine Embry — MolDx Technical Assessment Director
Note: RAS, like CFI, is a government contractor and is not a traditional adverse party. RAS was checked for any current or recent representation by the Firm.
3. Centers for Medicare & Medicaid Services ("CMS")
Federal agency within the United States Department of Health and Human Services.
Relationship to Engagement: CMS is the federal agency responsible for administering the Medicare program, including establishing national coverage policies and overseeing the MAC and MolDx programs. The proposed engagement may involve direct or indirect interaction with CMS if the NCD pathway is pursued.
Note: As a federal government body, CMS cannot be a "client" of the Firm. Pursuant to Firm policy, no conflict arises from representation of a client in matters involving submissions to or interactions with a federal agency. However, the Firm's conflicts database was checked for any concurrent representation adverse to CMS in matters involving molecular diagnostics coverage, genomic testing reimbursement, or related subject matter that could give rise to a positional conflict.
4. American Medical Association ("AMA") — CPT Editorial Panel
Relationship to Engagement: The AMA CPT Editorial Panel is the body responsible for maintaining the Current Procedural Terminology ("CPT") code set, including Proprietary Laboratory Analyses ("PLA") codes. The proposed engagement will include preparation and submission of a PLA code application for the OncoPrecise GXP-47 test to the AMA CPT Editorial Panel.
Note: The AMA CPT Editorial Panel is a standard-setting and regulatory body. The Firm's conflicts database was checked for any current representation that could create a positional conflict with respect to CPT or PLA coding submissions, including any representation of a client that has taken or may take a position before the AMA CPT Editorial Panel that is inconsistent with the positions to be advanced on behalf of GDT.
D. Other Involved Third Parties and Advisors
The following entities and individuals were identified as third parties and advisors involved in or related to the proposed engagement and were included in the conflicts search.
1. Whitford & Sable LLP
Also searched as: "Whitford Sable," "W&S"
Entity Type: Limited Liability Partnership (California)
Principal Office: 501 West Broadway, Suite 1400, San Diego, CA 92101
Relationship to GDT/Engagement: Whitford & Sable LLP serves as GDT's regular outside counsel for corporate and intellectual property matters. Co-counsel coordination is anticipated between Calderwood & Harkness and Whitford & Sable on matters involving the intersection of Medicare coverage strategy and GDT's broader corporate and intellectual property positions.
Key Personnel Checked:
• Harrison Whitford — Lead Partner
• Danielle Reeves — Associate
Note: Whitford & Sable was checked for adverse representations by the Firm. Additionally, it is noted that Theresa Nakamura, GDT's General Counsel, is a former associate of Whitford & Sable LLP (see Section III for further discussion).
2. Ashby & Garner, LLP
Also searched as: "Ashby Garner," "A&G"
Entity Type: Limited Liability Partnership (New York)
Principal Office: 599 Lexington Avenue, 22nd Floor, New York, NY 10022
Relationship to GDT/Engagement: Ashby & Garner, LLP serves as outside counsel to Pinnacle Health Ventures, L.P., GDT's majority investor, on portfolio company matters. Ashby & Garner may interact with Calderwood & Harkness on board-level decisions relating to GDT's Medicare coverage strategy, particularly to the extent that such strategy has implications for GDT's valuation and the timing of future financing events.
Key Personnel Checked:
• Robert Garner — Partner
3. Larkfield Health Economics, LLC
Also searched as: "Larkfield Health," "Larkfield HEOR"
Entity Type: Limited Liability Company (Maryland)
Principal Office: 7910 Woodmont Avenue, Suite 610, Bethesda, MD 20814
Relationship to GDT/Engagement: Larkfield Health Economics, LLC is a health economics and outcomes research ("HEOR") consulting firm retained by GDT to develop the clinical utility and economic evidence package supporting Medicare coverage for the OncoPrecise GXP-47 test. Larkfield's work product will be utilized in LCD and MolDx submissions prepared with Calderwood & Harkness's guidance.
Key Personnel Checked:
• Dr. Nathan Ostroff — Principal Consultant
4. Carraway Regulatory Advisors, Inc.
Also searched as: "Carraway Regulatory," "Carraway Advisors," "CRA"
Entity Type: Corporation (Illinois)
Principal Office: 233 South Wacker Drive, Suite 4100, Chicago, IL 60606
Relationship to GDT/Engagement: Carraway Regulatory Advisors, Inc. is a coding and billing consulting firm retained by GDT to provide CPT and PLA coding expertise. Carraway will work alongside the Calderwood & Harkness engagement team on coding strategy, including the preparation of the PLA code application and the development of crosswalk and gapfill reimbursement rate analyses.
Key Personnel Checked:
• Janet Carraway, CPC, CCS-P — Principal
5. Verdant Life Sciences Capital, LLC
Also searched as: "Verdant Life Sciences," "Verdant Capital," "VLSC"
Entity Type: Limited Liability Company (California)
Principal Office: 101 Montgomery Street, Suite 2600, San Francisco, CA 94104
Relationship to GDT/Engagement: Verdant Life Sciences Capital, LLC is serving as GDT's investment banking and financial advisory firm. Verdant is advising GDT on pre-commercial valuation and a potential Series D financing round and/or initial public offering ("IPO"). Medicare reimbursement revenue projections for the OncoPrecise GXP-47 test are being modeled into GDT's forward financial projections, and the outcome of the Medicare coverage and coding engagement will have a direct impact on Verdant's valuation analysis.
Key Personnel Checked:
• Christine Lau — Managing Director
6. Pacific Coast National Bank ("PCNB")
Also searched as: "Pacific Coast National," "PCNB," "Pacific Coast Bank"
Entity Type: National Banking Association (California)
Principal Office: 633 West 5th Street, 18th Floor, Los Angeles, CA 90071
Relationship to GDT/Engagement: PCNB is GDT's commercial lender. PCNB extended a $15 million Revolving Credit Facility to GDT pursuant to a Credit Agreement dated September 22, 2023 (Reference No. PCNB-GDT-RF-2023-0922). Of particular relevance to the proposed engagement, Section 7.14 of the Credit Agreement contains a milestone covenant requiring GDT to obtain a Medicare coverage determination for the OncoPrecise GXP-47 test by no later than December 31, 2024. Failure to achieve this milestone constitutes an Event of Default under the Credit Agreement.
Key Personnel Checked:
• Thomas Becerra — Relationship Manager
Note: PCNB was checked for current representations by or adverse to the Firm, given that the outcome of the proposed engagement could have direct implications for GDT's compliance with the PCNB Credit Agreement milestone covenant.
7. Hawthorne Mutual Insurance Company
Also searched as: "Hawthorne Mutual," "Hawthorne Insurance," "HMI"
Entity Type: Mutual Insurance Company (Connecticut)
Principal Office: 280 Trumbull Street, Suite 1200, Hartford, CT 06103
Relationship to GDT: Hawthorne Mutual Insurance Company is GDT's directors' and officers' liability insurer and professional liability insurer.
• Directors & Officers Liability Policy No. HMI-DL-2023-04891 (aggregate limit: $10,000,000)
• Professional Liability Policy No. HMI-PL-2023-07234 (aggregate limit: $5,000,000)
Key Personnel Checked:
• Megan Forsythe — Underwriter
8. Summit Ridge Accounting Group, LLP
Also searched as: "Summit Ridge Accounting," "Summit Ridge," "SRAG"
Entity Type: Limited Liability Partnership (California)
Principal Office: 1250 Sixth Avenue, Suite 800, San Diego, CA 92101
Relationship to GDT: Summit Ridge Accounting Group, LLP serves as GDT's independent auditor.
Key Personnel Checked:
• Brian Castellano, CPA — Engagement Partner
E. Competitive / Related Entities (Product Comparators)
The following entities were identified as competitors of GDT whose products have been identified as crosswalk comparators for purposes of the Medicare reimbursement rate analysis that is a component of the proposed engagement. Because GDT's reimbursement rate strategy will involve direct comparison of the OncoPrecise GXP-47 test to these entities' products, and because Calderwood & Harkness's advocacy on behalf of GDT could affect the competitive positioning of these entities' tests in the Medicare reimbursement landscape, these entities were included in the conflicts search.
1. Elara Genomic Sciences, Inc.
Also searched as: "Elara Genomic," "Elara Genomics," "EGS"
Entity Type: Corporation (Massachusetts)
Relationship to Engagement: Elara Genomic Sciences, Inc. is the proprietor of "GeneSight Onco-48," a genomic diagnostic test that has been assigned PLA Code 0250U. GeneSight Onco-48 has been identified by GDT and its consultants as a primary crosswalk comparator for establishing the Medicare reimbursement rate for OncoPrecise GXP-47.
2. Marlowe Asset Management Molecular Diagnostics, Inc.
Also searched as: "Marlowe Asset Management Molecular," "Marlowe Asset Management Diagnostics," "VMD"
Entity Type: Corporation (California)
Relationship to Engagement: Marlowe Asset Management Molecular Diagnostics, Inc. is the proprietor of "TumorMap Pro," a genomic diagnostic test that has been assigned PLA Code 0239U. TumorMap Pro has been identified by GDT and its consultants as a secondary crosswalk comparator for the Medicare reimbursement rate analysis.
F. Additional Entities and Individuals Checked
The following additional entities and individuals were included in the conflicts search based upon their affiliations with GDT board members or involvement in GDT's clinical development activities.
Harborview Diagnostics, Inc. — Corporation; former employer of Dr. Franklin Mosley, independent director of GDT. Dr. Mosley served as Chief Medical Officer of Harborview Diagnostics, Inc. prior to his appointment to the GDT Board of Directors.
Altius Biosciences, Inc. — Corporation; former employer of Catherine Hwang, independent director of GDT. Ms. Hwang served as Chief Financial Officer of Altius Biosciences, Inc. prior to her appointment to the GDT Board of Directors.
Dr. Evelyn Matsuda — Chair of the Data Safety Monitoring Board ("DSMB") for the CLARITY-LUNG clinical validation trial (NCT05891247). Dr. Matsuda is affiliated with the Carrington Cancer Institute and may be involved in the preparation or review of clinical evidence supporting the Medicare coverage submission.
Carrington Cancer Institute — Located at 7500 Fannin Street, Houston, TX 77054. Institutional affiliation of Dr. Evelyn Matsuda.
III. Conflicts Database Search Methodology
The conflicts review was conducted in accordance with the Firm's Conflicts of Interest Policy (revised January 1, 2024) and applicable Rules of Professional Conduct, including Rule 1.7 (Conflict of Interest: Current Clients), Rule 1.9 (Duties to Former Clients), and Rule 1.10 (Imputation of Conflicts of Interest) of the Model Rules of Professional Conduct, as adopted in the jurisdictions in which the Firm maintains offices relevant to this engagement (District of Columbia and California).
Search Parameters. The conflicts search was conducted using the following search parameters for each party identified in Section II above:
(a) Full legal names of all entities, including all known variations, abbreviations, trade names, and "doing business as" names;
(b) Short names and commonly used acronyms (e.g., "GDT," "PHV," "CFI," "RAS," "PCNB");
(c) Employer Identification Numbers, where available (e.g., GDT EIN 83-2947156);
(d) National Provider Identifier numbers, where applicable (e.g., GDT NPI 1902847365);
(e) Full legal names of all individual principals, board members, officers, and key contacts identified in Section II.B through II.F, including maiden names and known aliases; and
(f) Organizational affiliations of all individuals, including current and former employers and board memberships.
Databases and Sources Searched. The following databases and sources were searched during the course of this review:
(a) Calderwood & Harkness New Business Intake ("NBI") System — The Firm's centralized conflicts management database, which contains records of all new client engagements, matter openings, and adverse party designations across all Firm offices. The NBI System was searched using all parameters identified above.
(b) All-Office Client/Matter Database — The Firm's comprehensive database of all current and former client representations, including matter descriptions, party rosters, billing records, and engagement status. This database encompasses records from all offices of Calderwood & Harkness LLP.
(c) Lateral Hire Portability Records — Records of prior representations and client relationships disclosed by lateral hire attorneys upon joining the Firm, maintained in the Firm's lateral hire conflicts database. This search was particularly relevant to Sean Morrissey, Senior Associate, who joined the Firm from the federal government (see below).
(d) External Public Filings — Secretary of State corporate records for the states of Delaware, California, Oregon, South Carolina, Massachusetts, Illinois, New York, Connecticut, and Maryland were reviewed to confirm the legal names, entity types, and registered agents of all entities included in the search. SEC EDGAR filings were reviewed as applicable for publicly available information regarding the entities and individuals checked.
Practice Group Cross-References. The results of the database searches were cross-referenced with the active matter lists of the following practice groups, which were identified as having the greatest potential for overlap with the subject matter of the proposed engagement:
(a) Healthcare & Life Sciences Practice Group — active matter list reviewed as of February 9, 2024; and
(b) Life Sciences Regulatory Practice Group — active matter list reviewed as of February 9, 2024.
No overlapping or potentially conflicting matters were identified in either practice group's active matter list.
Lateral Hire Check — Sean Morrissey. Sean Morrissey, Senior Associate in the Firm's Washington, D.C. office, is a proposed member of the engagement team. Prior to joining Calderwood & Harkness in September 2022, Mr. Morrissey served as a policy analyst in the Coverage and Analysis Group ("CAG") at the Centers for Medicare & Medicaid Services. Given Mr. Morrissey's prior government employment, the Conflicts Review Unit conducted an enhanced review to determine whether any revolving-door restrictions or recusal obligations applied. This review confirmed the following:
(a) Mr. Morrissey had no involvement in any coverage decisions, policy analyses, technical assessments, or other official actions relating to GDT, the OncoPrecise platform, or any GDT-related entity during his tenure at CMS;
(b) The proposed engagement involves advisory and regulatory strategy work that is non-governmental in nature and does not involve representation of a client before CMS in a contested proceeding or formal adjudication that would trigger the post-employment restrictions of 18 U.S.C. § 207;
(c) Mr. Morrissey's post-employment cooling-off period under 18 U.S.C. § 207(c) expired in September 2023, and in any event, the proposed engagement does not involve the type of representational activity to which that provision applies; and
(d) No recusal is required, and no conflict of interest exists with respect to Mr. Morrissey's participation in the proposed engagement.
Theresa Nakamura — Former Associate at Whitford & Sable LLP. During the course of the conflicts review, it was noted that Theresa Nakamura, GDT's General Counsel and the primary client contact for the proposed engagement, was formerly an associate attorney at Whitford & Sable LLP. The Conflicts Review Unit confirmed that Ms. Nakamura's tenure at Whitford & Sable did not overlap with any matters handled by Calderwood & Harkness involving or adverse to Whitford & Sable, and that no Calderwood & Harkness personnel had any professional relationship with Ms. Nakamura during her tenure at that firm. This notation is included for completeness and does not give rise to any conflict of interest.
IV. Results of Conflicts Check
A. No Conflicts Identified
Based upon the comprehensive review described in Sections II and III above, the Conflicts Review Unit has determined that no conflicts of interest have been identified that would preclude Calderwood & Harkness LLP from accepting the proposed engagement of Genome Dx Therapeutics Inc. as a new client of the Firm for Matter No. 1043-00002.
Specifically, the review confirmed the following:
(a) No Current or Former Client Relationships with GDT or Its Affiliates. The Firm has no current or former client relationship with Genome Dx Therapeutics Inc., Pinnacle Health Ventures, L.P., Pinnacle Health Ventures Management, LLC, Westbrook Life Sciences Fund, L.P., or any officer, director, or affiliate of GDT identified in Section II.A and II.B above.
(b) No Representations of Government Contractors. The Firm has no current representation of Cascade Fiscal Intermediaries, LLC, Ridgeline Administrative Services, LLC, or any personnel thereof. A prior closed matter involving RAS is noted in Section IV.B below but does not constitute a conflict.
(c) No Conflicting Representations Involving PCNB. The Firm has no current representation of or adverse to Pacific Coast National Bank in any matter that would create a conflict of interest with respect to the proposed GDT engagement. A prior closed matter involving PCNB is noted in Section IV.B below but does not constitute a conflict.
(d) No Client Relationships with Comparator Entities. The Firm has no current or former client relationship with Elara Genomic Sciences, Inc. or Marlowe Asset Management Molecular Diagnostics, Inc. The Firm does not represent any entity whose interests would be materially adversely affected by the reimbursement rate analysis and crosswalk strategy to be developed on behalf of GDT.
(e) No Adverse Representations Involving Co-Counsel or Advisors. The Firm has no current representation of or adverse to Whitford & Sable LLP, Ashby & Garner, LLP, Larkfield Health Economics, LLC, Carraway Regulatory Advisors, Inc., Verdant Life Sciences Capital, LLC, Hawthorne Mutual Insurance Company, or Summit Ridge Accounting Group, LLP in any matter that would create a conflict of interest.
(f) No Positional Conflicts with Government or Regulatory Bodies. No positional conflicts have been identified with respect to CMS or the AMA CPT Editorial Panel. The Firm is not currently representing any client in a matter that involves taking a position before CMS on molecular diagnostics coverage that is inconsistent with the positions to be advanced on behalf of GDT. Similarly, the Firm is not currently representing any client in a matter that involves taking a position before the AMA CPT Editorial Panel on CPT or PLA coding that is inconsistent with the positions to be advanced on behalf of GDT.
(g) No Conflicts Arising from Additional Entities or Individuals. The Firm has no current or former client relationship with Harborview Diagnostics, Inc., Altius Biosciences, Inc., Carrington Cancer Institute, or Dr. Evelyn Matsuda that would create a conflict of interest.
B. Matters Noted (Non-Conflict)
The following matters were identified during the conflicts review as requiring notation for informational purposes. None of these matters constitutes a conflict of interest that would preclude acceptance of the proposed engagement, but they are documented here in accordance with the Firm's practice of maintaining a complete record of all matters reviewed during the conflicts process.
1. Ridgeline Administrative Services, LLC — Prior Closed Matter
Calderwood & Harkness represented an unrelated client in connection with a MolDx technical assessment matter in 2021 (Matter No. 1013-00004, "MolDx Technical Assessment Appeal — [Client Name Redacted]"). That matter was closed upon completion of the technical assessment appeal, and the Firm has no ongoing relationship with Ridgeline Administrative Services, LLC. During the course of the 2021 matter, the Firm did not take any adverse position against RAS, but rather assisted the client in navigating the technical assessment process. The subject matter of the 2021 engagement involved a different diagnostic test in an unrelated clinical area (cardiovascular risk assessment), and there is no substantive overlap with the proposed GDT engagement. Conclusion: No conflict.