Steve Tamayo
Senior Counsel
Steve advises medical device and pharmaceutical companies on compliance best practices, fraud and abuse laws, commercial and promotional activities, transparency requirements, and enterprise risk matters. He brings extensive in-house experience to his practice, having served in senior legal and compliance leadership positions at Sight Sciences, Alcon Laboratories, C. R. Bard, Shionogi, and Dey Pharma L.P.
Steve's practice is shaped by years of advising companies from inside the business. He has worked directly with boards, executive leadership, legal teams, and business functions on legal and compliance issues involving a range of activities, such as industry interactions with healthcare providers, acquisitions, patient support programs, discount arrangements, and other commercial activities. His experience spans the Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practices Act, HIPAA, GDPR, FDA promotional requirements, and healthcare transparency requirements.
A significant part of Steve's experience involves compliance program design and implementation, risk assessments, monitoring and auditing, internal investigations, policy development and training, and compliance due diligence. Steve also brings public-company governance experience, including IPO readiness, SEC-related governance initiatives, chairing ethics and compliance committees, co-leading enterprise risk management, and contributing to SEC filings and sustainability reporting.
Focus Areas
- Healthcare fraud and abuse, including the Anti-Kickback Statute, False Claims Act, and OIG guidance.
- Anti-corruption and FCPA compliance
- Compliance program design, implementation, and risk assessment
- Internal investigations and compliance remediation
- Compliance monitoring and auditing
- Regulatory and compliance diligence in M&A transactions
- Compliance policies, training, and education
- Commercial and promotional compliance
Representative Experience
- Develops and implements compliance programs for medtech and pharma companies, including policies, procedures, training, monitoring, and auditing.
- Advises boards and executive leadership on compliance and regulatory matters affecting commercial strategy, market access, product strategy, market expansion, and enterprise risk.
- Leads compliance investigations and case-management, including investigation strategy and the development of corrective and remediation measures.
- Advises on compliance with the Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practices Act, HIPAA, GDPR, and FDA promotional requirements.
- Counsels on healthcare provider interactions and commercial arrangements, including patient support programs and discount arrangements, with a focus on fraud and abuse and related compliance risks.
- Advises on the design and implementation of reimbursement support programs, with a focus on healthcare fraud and abuse risk.
- Supports public-company compliance and governance matters, including IPO readiness, SEC filings, sustainability reporting, conflict minerals reporting, and transparency reporting.
Differentiators
- Brings an in-house perspective to client counseling, translating complex compliance and regulatory requirements into practical solutions for clients.
- Deep experience with healthcare fraud and abuse, OIG Guidance, AdvaMed and PhRMA Code compliance, promotional compliance practices, and transparency requirements.
- Experience building, operating, assessing, and enhancing compliance programs from inside regulated organizations.
- Public-company governance experience involving IPO readiness, SEC-related reporting, sustainability reporting, and enterprise risk management.
Education
- J.D., University of Oregon School of Law
- B.A., Sociology, University of California, Santa Barbara
Admissions & Affiliations
- State Bar of New Jersey
- U. S. District of New Jersey
- American Health Law Association
Personal
Steve is a big fan of action and spy novels, so he is always up for a good international conspiracy, at least from the comfort of a good chair. He and his wife love traveling to new places, and when home, they enjoy spending as much time as we can with their two grandchildren.