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Contract analysis / letter-to-pinnacle-re-lab-interface-cme.docx
letter-to-pinnacle-re-lab-interface-cme.docx
1010-00003 · 15 clauses
High · 1 Medium · 3 Standard · 1
I. Introduction and Purpose of This Letter
I. Introduction and Purpose of This Letter This firm serves as healthcare regulatory counsel to Arbor Health Technologies Inc. ("AHT"), a Delaware corporation headquartered at 200 Concord Avenue, Suite 400, Cambridge, Massachusetts 02138. AHT operates twenty-three (23) outpatient clinics branded as "Arbor Health Clinics" across the Commonwealth of Massachusetts, the State of Connecticut, the State of Rhode Island, an
1. The provision by Pinnacle of an electronic laboratory interface to AHT at no cost;
1. The provision by Pinnacle of an electronic laboratory interface to AHT at no cost;
2. Pinnacle's sponsorship of continuing medical education ("CME") events for AHT physicia
2. Pinnacle's sponsorship of continuing medical education ("CME") events for AHT physicians; and
3. An ownership and investment interest held by a family member of AHT's Chief Executive Medium
⚑ Forum / governing law
3. An ownership and investment interest held by a family member of AHT's Chief Executive Officer in Pinnacle. We wish to emphasize at the outset that this letter is not an accusation of wrongdoing by Pinnacle. Rather, AHT is writing in a spirit of cooperation and transparency to share the substance of its compliance findings and to initiate good-faith discussions aimed at restructuring certain elements of the parties
II. Background of the Relationship
II. Background of the Relationship A. The Preferred Laboratory Agreement AHT and Pinnacle entered into the Preferred Laboratory Agreement effective June 15, 2020. Under the Agreement, AHT clinics located in Rhode Island and southeastern Massachusetts refer outpatient clinical laboratory testing to Pinnacle. The referral relationship encompasses a range of clinical laboratory services, including routine blood chemistr
III. Compliance Concern No. 1 — No-Cost Electronic Laboratory Interface High
⚑ Penalty / liquidated damages
III. Compliance Concern No. 1 — No-Cost Electronic Laboratory Interface A. Stark Law Analysis — Non-Monetary Remuneration Exception The Stark Law, 42 U.S.C. § 1395nn(a), prohibits a physician from making referrals for designated health services — which expressly include clinical laboratory services — to an entity with which the physician (or an immediate family member of the physician) has a financial relationship, u
IV. Compliance Concern No. 2 — CME Event Sponsorship Standard
⚑ Commercial term
IV. Compliance Concern No. 2 — CME Event Sponsorship A. Description of Sponsorship Activity As noted above, Pinnacle sponsored four (4) continuing medical education events for AHT physicians during fiscal year 2022, at a total cost of $86,000. These events were provided in the context of the ongoing referral relationship in which AHT physicians — the same physicians who attend and benefit from the sponsored education
V. Compliance Concern No. 3 — Dr. Karen Ellsworth's 4.2% Passive Equity Interest in Pinnac
V. Compliance Concern No. 3 — Dr. Karen Ellsworth's 4.2% Passive Equity Interest in Pinnacle A. Nature of the Concern Our compliance self-assessment has identified that Dr. Karen Ellsworth, a licensed physician (MD) who maintains an independent medical practice and is not employed by AHT, holds a 4.2% passive equity interest in Pinnacle Laboratory Services Inc. (EIN: 05-6138290). Dr. Karen Ellsworth is the spouse of
VI. Summary of Requested Restructuring Actions
VI. Summary of Requested Restructuring Actions For the convenience of Pinnacle's officers and counsel, we summarize below the three areas requiring restructuring discussions:
1. Electronic Laboratory Interface. The no-cost provision of the electronic laboratory in
1. Electronic Laboratory Interface. The no-cost provision of the electronic laboratory interface must be converted to a fair market value license or subscription arrangement. The fair market value will be established by an independent appraisal conducted by Northbridge Valuation Advisors LLC. The license arrangement must be documented in a separate written agreement meeting the requirements of an applicable Stark Law
2. CME Sponsorship. Direct CME sponsorship by Pinnacle that is linked to the referral rel
2. CME Sponsorship. Direct CME sponsorship by Pinnacle that is linked to the referral relationship must be discontinued, or alternatively restructured so that any future educational support is provided through an independent, ACCME-accredited continuing medical education organization with no referral-conditioned elements. Any CME support arrangement must be entirely separate from the Preferred Laboratory Agreement, w
3. Dr. Karen Ellsworth's Equity Interest. Pinnacle is requested to cooperate in the discl
3. Dr. Karen Ellsworth's Equity Interest. Pinnacle is requested to cooperate in the disclosure, documentation, and analysis of Dr. Karen Ellsworth's 4.2% passive equity interest in Pinnacle. The parties should discuss potential divestiture of the interest or the implementation of structural safeguards sufficient to mitigate the compliance risk. AHT is concurrently implementing internal recusal procedures and referral
VII. Proposed Next Steps and Timeline
VII. Proposed Next Steps and Timeline AHT proposes that the parties schedule a meeting — in person at a mutually convenient location or by videoconference — within thirty (30) days of the date of this letter to discuss the proposed restructuring measures described herein. AHT's representatives for this discussion will include Patricia Yamamoto, General Counsel of AHT; Derek Huang, Chief Compliance Officer of AHT; and
VIII. Confidentiality and Privilege Medium
⚑ Forum / governing law
VIII. Confidentiality and Privilege This letter is written at the direction of AHT's General Counsel, Patricia Yamamoto, and Chief Compliance Officer, Derek Huang, in connection with a privileged compliance self-assessment being conducted under the oversight of AHT's Board of Directors and Compliance Committee. The legal analyses referenced herein are protected by the attorney-client privilege and the work product do
IX. No Admission Medium
⚑ Liability cap to check against exposure
IX. No Admission Nothing in this letter should be construed as an admission by AHT of any violation of federal or state law, including but not limited to the Anti-Kickback Statute, the Stark Law, the False Claims Act, or any analogous state statute or regulation. AHT is undertaking this self-assessment and the proposed remediation measures proactively and in good faith as part of a comprehensive corporate compliance