• Converted to employee after contract engagement via Axiom (see above). 30% workforce reduction resulted in elimination of this position as of 12/01/2022.
• Provided legal support for integration of Silicon Therapeutics after 2021 merger with Roivant Sciences, Inc., and served as lead counsel for Roivant Discovery, Inc., Psivant Therapeutics, Inc., Covant Therapeutics, Inc. and VantAI, Inc.
• Negotiated and drafted high volume of complex R & D and other agreements under aggressive deadlines in a fast-moving environment, including MSA’s, manufacturing and development agreements, SOWs, CRO agreements, quality agreements, research collaboration agreements, inbound and outbound licenses, material transfer agreements, SaaS agreements, consulting agreements, BAA’s and NDA’s.  This role focused particularly on intellectual property terms and cross-border legal risk.
• Collaborated extensively with corporate executives and development, risk management, information security, accounting and tax teams; participated in implementation of contracts management system; and supervised paralegals and legal operations staff on corporate governance and other matters.

CARDINAL HEALTH – Commercial Counsel (remote contract engagement) 2/2023 – 8/2023
• Negotiated and drafted nuclear pharmacy management SaaS and related pharmaceutical supply agreements with approximately 350 hospital and health system customers of Cardinal’s Nuclear & Precision Health Solutions business, supporting implementation of major product upgrades within aggressive deadlines.
• Negotiated and drafted wide variety of complex agreements, e.g., hospital pharmacy management, reseller, GPO, vendor, consulting and sourcing agreements, NDA’s, data security addenda and HIPAA BAA’s, with particular focus on product warranties, data security and privacy protection terms and compliance of pricing and rebate terms with the Anti-Kickback Statute and OIG Advisory Opinions.  
• Participated in PRC and regularly collaborated with corporate executives and sales, development, information security, finance and HR teams.

ROIVANT SCIENCES, INC. – Commercial Counsel (remote contract engagement) 6/2021 – 12/2021 
• Converted to employee, 12/01/2021, following Axiom engagement.  See description of role below.

JOHNSON & JOHNSON – Regulatory Counsel (remote contract engagement) 10/2020 – 4/2021
• Provided regulatory counsel to in-house commercial counsel and operations teams regarding compliance with the Physician Payments Sunshine Act, Foreign Corrupt Practices Act, Anti-Kickback Statute and Pharma Code.
• Negotiated and drafted funding agreements with recipients of grants from the Johnson & Johnson Foundation, speaker and consulting agreements with health care professionals and advisory board agreements. 
• Participated in PRC and reviewed draft promotional and educational materials, including social media content, for general legal risk and FDA compliance.

VERILY LIFE SCIENCES, LLC – Product Counsel (remote contract engagement) 1/2020 – 7/2020
• Provided product counsel to cross-functional teams from pre-launch through commercial phase.  
• Regulatory advice included compliance of proposed marketing plans and joint ventures with the Anti-Kickback Statute, False Claims Act and state laws governing telemedicine and corporate practice of medicine limitations.
• Provided guidance on compliance with CLIA and California law in licensing of new clinical laboratory. Regularly reviewed draft informed consent forms and negotiated and drafted contract terms implicating HIPAA, Part 2 rules and the GDPR.

• Left this position due to unrealistic 3 to 3-1/2 hour daily commute on So Cal freeways.
• Served as in-house counsel for non-profit hospital and health system; negotiated and prepared variety of agreements, e.g., physician call coverage, professional services, hospitalist, physician recruitment, management services, vendor, construction, SaaS, software license and data use agreements, physician timeshare subleases and BAA’s. 
• Provided legal support for physician practice acquisitions by friendly PC.
• Attended monthly meetings and provided legal support to three hospital boards of directors, including legal review of board minutes and resolutions.

 [Converted to employee status after contract engagement via JURISolutions Legal, Inc., 1/2018 through 3/2018]
•  Lead counsel for health plan operations in Utah and Idaho.
•  Negotiated and settled payment disputes with hospitals, long-term care facilities and physician groups. 
•  Drafted comprehensive enterprise-wide information technology contracts. 
•  Advised corporate and health plan executives on HIPAA and related state privacy law compliance.  

Practice Highlights:

• Successfully appealed revocation of physician’s Medicare enrollment. 
• Advised surgeon on regulatory and corporate issues raised by proposed co-location of two surgery centers in a single clinic space. 
• Provided guidance and counsel to physician on compliance of proposed investment in ambulatory surgery center with the Anti-Kickback Statute ASC Safe Harbor and applicable state fraud and abuse laws.
• Counseled clinical psychologist on legal risk in billing for professional services performed by unlicensed psychological technicians for Medicare beneficiaries and legal obligations of self-disclosure and refund of overpayments.

[Left this position due to firm's cancellation of plans to open a Los Angeles office]

Practice Highlights:
• Represented hospice on appeal from post-audit Medicare overpayment determination and obtained reversal of recoupment.
• Advised clinic provider on self-disclosure and refund process following self-investigation of Medicare overpayment liability arising from documentation and billing errors.
• Represented FQHC in appeal from recoupment and denial of Medi-Cal managed care payments.
• Negotiated comprehensive data use agreement for consortium of FQHC's with a California county health and hospital system.
• Structured and documented "friendly PC" arrangement between charitable foundation and professional medical corporation.
• Provided legal guidance to home health agency regarding change of ownership and interim management arrangement with a prospective buyer.

[Dedicated several months to attend to family matters following departure from this position]
• In-house transactional and regulatory counsel for investor-owned hospitals, IPA's, ACO's, physician groups, home health agencies, long-term care providers and related MSO's with multi-state operations.
• Negotiated and prepared managed care payor contracts, agreements for physician emergency coverage, hospitalist and other professional services, physician recruitment, medical directorship, under-arrangements services for hospitals, clinical trial directorship, physician consulting, leases, third-party vendor arrangements, technology licensing and non-disclosure agreements.
• Provided guidance to corporate development and hospital executives on sensitive and complex matters, e.g., negotiation of conditional use permits and certificate of need applications.

Practice Highlights:
•    Counseled large genetic laboratory client on potential FDA exercise of regulatory oversight of laboratory-developed tests, compliance of marketing strategies and compensation arrangements with the Anti-Kickback Statute, Stark and other fraud and abuse laws.
•    Negotiated and drafted under-arrangements agreements with large hospital systems and provider agreements with health plans and IPA’s. 
•    Successfully appealed termination of home health agency provider by the California Department of Social Services and reinstatement as contracted provider for regional centers.  

•    Served as in-house regulatory counsel for publicly-traded entity and affiliated hospitalist physician groups throughout the United States. 
•    Negotiated and drafted ACO agreements, value-based compensation arrangements, hospital-based physician contracts, BAA’s and vendor agreements. 
•    Provided regulatory support on hundreds of physician practice acquisitions and legal guidance regarding participation in Medicare Shared Savings Program ACO’s and commercial ACO’s, and compliance with Stark, the Anti-Kickback Statute, Civil Monetary Penalties Law, Medicare and Medicaid/Medi-Cal regulations and HIPAA. 

• Lead regulatory counsel supporting mergers and acquisitions for health care clients.
• Extensive interface with legal counsel and regulators at the California Department of Managed Health Care.