Drew R. Barnholtz

Drew R. Barnholtz brings over 25 years of corporate, entrepreneurial and law firm experience, focused on regulatory and transactional matters in the life sciences, health care, technology, finance and manufacturing industries.  His clients value his advice, knowing that it is informed by a career that is rich in the kinds of experience that yields keen insights, good judgement, and a bottom-line business orientation.

Drew served as a corporate lawyer whose transactional experience was particularly diverse.  He also knows first-hand the challenges faced by in-house counsel.  He served as Assistant General Counsel at Invacare Corporation, a $1+ billion manufacturer of durable medical equipment; and as Assistant General Counsel for University Hospitals, one of the nation’s leading health care systems.   In these positions Drew tackled a number of complex issues, including:

• Advising clients on commercial transactions, acquisitions/divestitures, compliance, licensure, bond financing, and a variety of agreements
• Drafting and implementing a range of compliance programs (including for HIPAA), policies and procedures, accreditation applications, and Plans of Correction for deficiencies cited in a survey
• Providing analysis and opinions on Stark and the Anti-Kickback Statute for pharmacy, post-acute, physician and lab clients
• Drafting a private placement memorandum, business plan and subscription agreement for a start-up company
• Providing regulatory interpretation and advice for medical equipment manufacturers regarding FDA registration and listing requirements
• Negotiating, as a key team member, a Consent Decree with the FDA, and the remediation and planning efforts required to comply with the Consent Decree

Drew has spoken to health care industry gatherings on numerous topics including the Affordable Care Act, responding to FDA investigations and negotiating consent decrees, and trends in hospice care investigations and enforcement, as well as written several articles.

Representative Matters

• FDA regulations, the False Claims Act, anti-kickback issues, and government contracting and pricing requirements
• FDA consulting regarding registration and compliance requirements for manufacturers, distributors, and technology providers (including 510(k), Pre-Market Authorization, and New Drug Application processes)
• Consent Decree Negotiation
• Procurement Negotiation for Software as a Service (SaaS), healthcare information technology, and digital health agreements for payers, distributors, and providers
• Drafting and negotiation of regulated SaMD (software as a medical device) agreements
• Negotiation of technology licenses, intellectual property licenses, clinical trials agreements, and material transfer agreements.
• Start-up financing and fundraising counsel for emerging biomedical and pharmaceutical investment firms and companies
• Contract negotiations with managed care organizations/health plans/insurance organizations
• Corporate practice of medicine, medical device, HIPAA and data governance, and emerging regulations related to digital health technology, including AI/ML product development.
• Anti-kickback analysis for rebate and discount agreements
• Application of the Free Trade Agreement and Buy American Act for manufacturing and sales throughout the world
• Telehealth regulations and compliance (50 State compliance).